INSTRUCTIONS FOR USE PENUMBRA COIL ... - Penumbra, Inc.

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R INSTRUCTIONS FOR USE PENUMBRA COIL SYSTEM 2. The coil/delivery pusher is secured to the introducer sheath by means of a friction lock. Advance the delivery pusher past the friction lock to free the coil. Withdraw the delivery pusher back into the introducer sheath until the friction lock engages to resheath the coil. 3. Carefully advance the coil out of the introducer sheath into heparinized saline. Examine the coil for kinks or other irregularities. If an irregularity is found, replace with a new coil. WARNING: Use of damaged coils may affect coil delivery and/or stability inside the aneurysm. 4. With the distal end of the introducer sheath pointed downward and submerged in saline, carefully retract the coil fully into the introducer sheath. 5. Introduce the distal end of the introducer sheath through the RHV into the hub of the microcatheter until the introducer sheath is firmly seated in the hub taper. Tighten the RHV around the introducer sheath to prevent retrograde flow of blood. Do not over-tighten. Excessive tightening could damage the coil or delivery pusher. 6. Transfer the coil into the microcatheter by gently advancing the delivery pusher in a smooth continuous manner. Once the flexible portion of the delivery pusher has entered the microcatheter, loosen the RHV and remove the introducer sheath over the delivery pusher’s proximal end. NOTE: To resheath the coil, backload the delivery pusher into the introducer sheath from the same end it came out, and with the distal end of the introducer sheath pointed downward carefully retract the coil fully into the introducer sheath until the friction lock engages. 7. Tighten the RHV on the delivery pusher to prevent retrograde blood flow while still allowing advancement of the delivery pusher. 8. Visually verify that the flushing solution is infusing normally. 9. Advance the delivery pusher until the coil fluoroscopy marker reaches the RHV. Fluoroscopic guidance should be initiated at this time. See Figure 1. Figure 1 10. Continue advancing the coil under fluoroscopic guidance to the desired site. If coil placement is not satisfactory, slowly retract by pulling the delivery pusher proximally. The coil can then be deployed again. If the coil size is inappropriate, remove and replace with an appropriately sized coil. WARNING: Advance and retract coil slowly. Remove the coil if unusual friction is encountered. If unusual friction is encountered on subsequent coils, remove the microcatheter and carefully examine for damage. WARNING: If resistance is encountered when retracting the coil, retract the microcatheter until the resistance subsides. WARNING: Do not rotate the delivery pusher during use. Rotating the delivery pusher may result in premature detachment, which could lead to coil migration. 11. Continue advancing the coil until the radiopaque marker on the delivery pusher aligns just beyond the microcatheter proximal radiopaque marker to form a “T”. At this point, the proximal end of the coil implant just exits 2 (68) the microcatheter tip. Tighten the RHV on the delivery pusher to prevent further movement. See Figure 2. Figure 2 WARNING: Verify repeatedly that the microcatheter is not under stress before coil detachment. Stored forces in the microcatheter could cause the tip to move during detachment, which could lead to aneurysm rupture. WARNING: Advancing the delivery pusher beyond the microcatheter tip could lead to aneurysm rupture. 12. Remove the Detachment Handle from its packaging and place it within the sterile field. 13. Reconfirm the delivery pusher radiopaque marker forms a “T” with the microcatheter proximal marker. NOTE: Coil detachment is not dependent on exact alignment, however, marker alignment will ensure that the proximal end of the coil implant just exits the microcatheter tip. 14. Hold the delivery pusher distal to the black alignment zone. Advance the Detachment Handle over the proximal end of the delivery pusher until the black alignment zone is fully concealed within the Detachment Handle funnel and the delivery pusher comes to a stop inside the Detachment Handle. See Figure 3. Figure 3 15. To detach the coil, use thumb to retract the Detachment Handle slider until it clicks. NOTE: After the slider clicks, release the slider to allow it to return to its original position. NOTE: The detachment mechanism will only activate upon hearing the click, not during the earlier phase of slider retraction.
R INSTRUCTIONS FOR USE PENUMBRA COIL SYSTEM 16. Gently pull back the delivery pusher under fluoroscopic guidance to ensure the coil has detached. 17. If the coil is still attached, repeat steps 14 and 15, or carefully withdraw the coil and redeploy another coil. 18. Repeat for all additional coils 19. Once the procedure is complete, discard the Detachment Handle. MR CONDITIONAL MRI INFORMATION Non-clinical testing has demonstrated the Penumbra Coil 400 is MR Conditional. It can be scanned safely under the following conditions: • static magnetic field of 1.5 Tesla or 3 Tesla • spatial gradient field of 2,500 Gauss/cm or less (extrapolated) • Normal operating mode only with a whole body averaged specific absorption rate (WBA SAR) of less than 2.0 W/kg and a head averaged SAR of less than 3.2 W/kg for 15 minutes of continuous scanning with the transmit body coil or the transmit head coil • Non-clinical testing, using measurement and electromagnetic in-vivo simulation analyses, was performed to assess the in-vivo heating of the Penumbra Coil 400. The Coil 400 produced an estimated in-vivo temperature rise < 2.5°C during 15 minutes of continuous MR scanning in the normal operating mode at a WBA SAR of 2.0W/kg and a head averaged SAR of 3.2 W/kg. This temperature rise is conservative, as it does not include the cooling effects of blood flow. ARTIFACT INFORMATION MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Penumbra Coil 400. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. MR image artifacts can affect the implant surrounding according to the tables below: 24mm spherical configuration (30% packing density) 1.5 Tesla Worst-case artifacts of Spin Echo Gradient Echo Test object length 3.7 mm 6.9 mm Test object width 3.1 mm 6.8 mm Test object height 1.2 mm 2.9 mm 3 Tesla Worst-case artifacts of Spin Echo Gradient Echo Test object length 3.9 mm 10.4 mm Test object width 4.5 mm 11.2 mm Test object height 3.6 mm 8.0 mm 8mm OD x 55mm cylindrical configuration (30% packing density) 1.5 Tesla Worst-case artifacts of Spin Echo Gradient Echo Test object length 1.8 mm 3.8 mm Test object width 1.9 mm 5.3 mm Test object height 2.8 mm 6.1 mm 3 (68) 3 Tesla Worst-case artifacts of Spin Echo Gradient Echo Test object length 4.6 mm 7.7 mm Test object width 3.5 mm 8.2 mm Test object height 3.8 mm 8.8 mm PACkAgINg AND STORAgE The Penumbra Coil System is packaged in a protective plastic dispenser hoop, pouch, and box. The Penumbra Coil System will remain sterile unless the pouch is opened, damaged, or the “Use By” date has passed. The Detachment Handle is packaged separately in a protective pouch and box. The Detachment Handle will remain sterile unless the pouch is opened, damaged, or the “Use By” date has passed. MATERIALS The Penumbra Coil System, Detachment Handle, and packaging do not contain latex. STORAgE Store in a cool dry place. SYMBOLS gLOSSARY LOT Rx Only Attention, see Instructions for Use Prescription only – US Federal Law restricts this device to use by or on the order of a physician Nonpyrogenic STERILE EO Sterilized using ethylene oxide XX cm 0.010" Coil Equivalent Length 0.025" ID Microcatheter Required Manufacturer EU Representative Lot number Do not reuse Use by REF Catalogue number Do not resterilize Latex free WARRANTY Penumbra Inc. (Penumbra) warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular use. Handling, storage, cleaning, and sterilization of this device as well as other factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond Penumbra’s control directly affect the device and the results obtained from its use. Penumbra’s obligation under this warranty is limited to the repair or replacement of this device and Penumbra shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this device. Penumbra neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. Penumbra assumes no liability with respect to devices reused, reprocessed, or re-sterilized and makes no warranties, expressed or implied, including but not limited to merchantability or fitness for intended use, with respect to such devices.
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