40-5124-24C IFU, ProPort.indd - Smiths Medical

[en]
TABLE OF CONTENTS PAGE
I. INTRODUCTION ........................................................................................ 3
A. Product Description ................................................................................................... 3
B. Indications for Use ..................................................................................................... 3
C. Contraindications ....................................................................................................... 3
D. Potential Complications ............................................................................................ 3
II. WARNINGS ................................................................................................ 4
III. PRE-IMPLANTATION CONSIDERATIONS ................................................. 4
A. Preparation of the System ......................................................................................... 4
A.1 Unassembled Systems ....................................................................................... 4
A.2 Pre-assembled or Preconnected Systems ...................................................... 4
IV. CATHETER PLACEMENT TECHNIQUES ..................................................... 4
A. Percutaneous Puncture – Method A (Interventional Radiologists) ................. 5
B. Percutaneous Puncture – Method B (Surgeons) .................................................. 5
C. Surgical Cutdown ....................................................................................................... 6
V. PORTAL AND SITE PREPARATION ............................................................. 6
A. Prepare Subcutaneous Pocket .................................................................................. 6
B. Catheter-Portal Assembly ......................................................................................... 6
B.1 SlideLock Connector ...................................................................................... 6
B.2 CATH-SHIELD® Connector ............................................................................ 6
C. Flow Check ................................................................................................................... 6
D. Site Closure .................................................................................................................. 7
E. Postoperative Care ...................................................................................................... 7
VI. INSTRUCTIONS FOR SYSTEM ACCESS ...................................................... 7
A. Determining System Integrity ................................................................................. 7
A.1 System Integrity is Verified – Portal Will Not Be Used Immediately ..... 7
A.2 System Integrity Is Verified – Injection Or Infusion Will Be Initiated
Immediately ........................................................................................................ 7
B. Flushing Schedule ....................................................................................................... 8
C. Blood Sampling Procedure (Venous Systems Only) ............................................ 8
D. Discontinuing System Use ........................................................................................ 8
E. References ..................................................................................................................... 8
FIGURES .......................................................................................................... 77
I. INTRODUCTION
ProPort implantable venous access systems can be placed in the chest and
are designed to permit repeated access to the venous system for the parenteral
delivery of medications, fluids, and nutritional solutions and for the sampling of
venous blood. These devices should be implanted only by clinicians experienced
or trained in the implantation and maintenance of venous access devices and
knowledgeable of the risks.
PRECAUTION: Patients who engage in occupations, or in physical activities,
such as golfing, swimming, or weight lifting, which involve excessive and /or
repetitive upper extremity and/or shoulder or pectoral girdle motion, should
be informed that such activity may increase the possibility of catheter fragmentation
due to compression of the catheter between the clavicle and first rib
(catheter pinch-off syndrome).
The figures referred to in this manual are found on a fold-out page inside the back
cover. Specifications for the portal and catheter are listed in the Product Specifications
booklet packaged with the product.
Patient Information and Clinician Information booklets can be obtained by contacting
Smiths Medical MD, Inc. in the U.S. at 1 800.426.2448 or Smiths Medical International
Ltd. the EU Authorized Representative at Tel +44 (0)1923 246434.
A. Product Description
ProPort systems are supplied sterile (EtO sterilized) and non-pyrogenic. All
ProPort products are designed and intended for single-patient use only. A
ProPort system consists of a portal with a self-sealing septum and a single-lumen
catheter and is accessible by percutaneous puncture with a non-coring needle.
Systems are also available with introducer sets.
B. Indications for Use
ProPort systems are indicated when patient therapy requires repeated venous
access for injection or infusion therapy and/or venous blood sampling.
C. Contraindications
ProPort systems are contraindicated for patient therapy whenever:
The presence of infection, bacteremia, or septicemia is known or suspected.
The patient’s anatomy will not permit introduction of the catheter into a
vessel.
The patient has severe chronic obstructive pulmonary disease (COPD) (chest
placement only).
The patient has undergone past irradiation of the upper chest area (chest
placement only).
The patient is known to have, or is suspected to have, an allergic reaction
to materials contained in the system or has exhibited a prior intolerance to
implanted devices. (System materials are listed in the Product Specifications
booklet and on the package label.)
Substances are used for patient therapy that are incompatible with any of the
system’s components. (System materials are listed in the Product Specifications
booklet and on the package label.)
Do not use this product if the package has been previously opened or damaged.
D. Potential Complications
Use of the system involves potential risks normally associated with the insertion
or use of any implanted device or indwelling catheter, including but not limited
to those listed below:
Air embolism
Arteriovenous fistula
Artery or vein damage/injury
Brachial plexus injury
Cardiac arrhythmia
Cardiac puncture
Cardiac tamponade
Catheter disconnection, fragmentation, fracture, or shearing with possible
embolization of the catheter 1,2,3,4,5,6,7,8
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• Catheter occlusion
• Catheter rupture
• Drug extravasation
• Erosion of portal/catheter through skin and/or blood vessel
• Fibrin sheath formation around catheter tip
• Hematoma
• Hemothorax
• Implant rejection
• Infection/bacteremia/sepsis
• Migration of portal/catheter
• Nerve damage
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