40-5091-24B IFU PAC-PACII.indd - Smiths Medical

English
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 ............................................................................... 5
A.1 Unassembled Systems ............................................................................. 5
A.2 Pre-assembled or Preconnected Systems ............................................. 5
IV. CATHETER PLACEMENT TECHNIQUES ........................................... 5
A. Per cutaneous Puncture – Method A
(Interventional Radiologists) .......................................................................... 5
B. Percutaneous Puncture – Method B (Surgeons) .......................................... 6
C. Surgical Cutdown ............................................................................................. 6
D. Arterial Placement (Arterial systems only) .................................................. 6
V. PORTAL AND SITE PREPARATION ...................................................
7
A. Prepare Subcutaneous Pocket ......................................................................... 7
B. Catheter-Portal Assembly ............................................................................... 7
B.1 ULTRA-LOCK® Connector ...................................................................... 7
B.2 CATH-SHIELD® Connector .................................................................. 7
B.3 WING-LOCK® Connector (Dual-lumen Systems) ............................ 7
C. Flow Check ........................................................................................................ 8
D. Site Closure ....................................................................................................... 8
E. Postoperative Care ........................................................................................... 8
VI. INSTRUCTIONS FOR SYSTEM ACCESS ............................................ 8
A. Determining System Integrity ........................................................................ 8
A.1 System Integrity is Verifi ed – Portal Will Not Be Used
Immediately ............................................................................................ 9
A.2 System Integrity Is Verifi ed – Injection Or Infusion Will Be
Initiated Immediately ............................................................................ 9
B. Flushing Schedule ............................................................................................ 9
C. Blood Sampling Procedure (Venous Systems Only) .................................... 9
D. Discontinuing System Use .............................................................................. 9
E. References ......................................................................................................... 9
FIGURES ................................................................................................ 91
I. INTRODUCTION
PORT-A-CATH® and PORT-A-CATH® II im plant able venous and arterial access
systems are designed to permit repeated access to the vascular system for the parenteral
delivery of medica tions, fl uids, and nutritional solutions and for the sam pling
of venous blood. Th ese devices should be implanted only by clinicians experienced
or trained in the implantation and maintenance of vascular access devices and
knowledgeable of the risks.
Venous systems may be placed in the arm or chest. Arterial systems are indicated for
direct organ perfusion.
Precaution: Patients who engage in occupations, or in physical activities, such as
golfi ng, 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 fi rst rib (catheter pinch-off
syndrome).
Th e fi gures referred to in this manual are found on a fold-out page inside the back
cover. Specifi cations for the portal and catheter are listed in the Product Specifi cations
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
PORT-A-CATH® and PORT-A-CATH® II systems are supplied sterile (EtO sterilized)
and non-pyrogenic. All PORT-A-CATH® and PORT-A-CATH® II products are
designed and intended for single-patient use only. A system con sists of a portal with
one or two self-sealing septa and a single- or dual-lumen catheter and is ac cessible
by percutaneous puncture with a non-coring needle. Systems are also available with
introducer sets.
B. Indications for Use
PORT-A-CATH® and PORT-A-CATH® II systems are indicated when patient
therapy requires repeated vascular access for injection or infu sion therapy and/or
venous blood sampling.
C. Contraindications
PORT-A-CATH® and PORT-A-CATH® II systems are contraindicated for patient
therapy whenever:
• Th e presence of infection, bacteremia, or septicemia is known or suspected.
• Th e patient's anatomy will not permit introduction of the catheter into a vessel.
• Th e patient has severe chronic obstructive pulmonary disease (COPD) (chest
placement only).
• Th e patient has undergone past irradiation of the upper chest area (chest placement
only).
• Th e 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 Specifi cations 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 Specifi cations
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 asso ciated with the insertion
or use of any implanted device or in dwelling catheter, including but not limited to
those listed below:
• Air embolism
• Arteriovenous fi stula
• 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
• Catheter occlusion
• Catheter rupture
• Drug extravasation
3