POLYSITE IMPLANTABLE INFUSION PORTS
Report
- Report Number
- 2245270-2023-00080
- Event Type
- Injury
- Date Received
- November 9, 2023
- Date of Event
- October 24, 2023
- Report Date
- February 20, 2024
- Manufacturer
- PEROUSE MEDICAL
- Product Code
- LJT
- PMA / PMN Number
- K122834
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
WE RECEIVED ONE USED SAMPLE FOR EVALUATION. THE DEVICE RECEIVED IS COMPOSED OF THE IMPLANTABLE PORT, THE CATHETER (25.3 CM), AND ITS RING. THE SERIAL NUMBER OF THE RETURNED PORT IS (B)(4). WE MANAGED TO TRACE LOT NUMBER 23010086 USING THE SERIAL LOT. ACCORDING TO THE AVAILABLE INFORMATION AND OUR EXPERIENCE, WE BELIEVE THAT THE MOST LIKELY HYPOTHESIS THAT COULD EXPLAIN THE CATHETER DISCONNECTION FROM THE IMPLANTABLE PORT COULD BE EXCESSIVE PRESSURE IN THE DEVICE, FOLLOWING A PHENOMENON OF OBSTRUCTION, LEADING TO THE DISCONNECTION OF THE CATHETER AND ITS MIGRATION. THE TITANIUM OUTLET TUBE SHOWS SEVERE DAMAGE, (PINCHED AND CRACKED). WE ASSUME THAT THIS DAMAGE WAS GENERATED DURING THE REMOVAL OF THE PORT, AS OTHERWISE, THE SURGEON WOULD NOT HAVE BEEN ABLE TO CONNECT THE CATHETER. DIMENSIONAL TESTS HAVE BEEN PERFORMED ON THE CATHETER AND THE RING: THE RESULTS ARE COMPLIANT WITH SPECIFICATIONS. FUNCTIONAL TESTS PERFORMED ON THE CATHETER AND THE PORT ARE COMPLIANT. HOWEVER, DURING THIS TEST, WE OBSERVED THE PRESENCE OF BLOOD IN SIGNIFICANT QUANTITIES, ESPECIALLY COAGULATED BLOOD IN THE CATHETER. THE RISK OF DAMAGE TO THE CATHETER DURING ATTEMPTING TO UNBLOCK UNDER PRESSURE IS CLEARLY DESCRIBED IN THE INSTRUCTION FOR USE (IFU # CD00632/003) OF POLYSITE (SECTION III-A WARNING AND PRECAUTIONS). EXTRACT: « NEVER TRY TO UNBLOCK THE DEVICE BY PRESSURE AND NEVER USE A SYRINGE SMALLER THAN 10 ML TO AVOID APPLYING EXCESSIVE PRESSURE WITHIN THE DEVICE. EXCESSIVE PRESSURE CAN DAMAGE THE CATHETER OR LEAD TO DISCONNECTION OF THE PORT». FURTHERMORE, TO AVOID ANY OBSTRUCTION OF THE CATHETER BY BLOOD, POSITIVE PRESSURE MUST BE SYSTEMATICALLY APPLIED WHEN REMOVING THE NEEDLE. INDEED, THE ABSENCE OF INJECTION CAUSES BLOOD REFLUX IN THE CATHETER WHICH CAN LEAD TO ITS OBSTRUCTION. THE REVIEW OF THE MANUFACTURING BATCH RECORD OF THE POLYSITE (B)(4) IMPLANTABLE PORT FINAL PRODUCT (LOT 23010086) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF THE INCIDENT. BASED ON VYGON USA COMPLAINT DATABASE (GRAND AVENUE), THIS IS THE FIRST COMPLAINT RECEIVED REGARDING THIS PRODUCT CODE AND LOT NUMBER. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THIS COMPLAINT COULD BE EXCESSIVE PRESSURE IN THE DEVICE, LEADING TO THE DISCONNECTION OF THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT.
THE MALFUNCTIONING DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW UP MDR.
PORT TUBING BECAME DISLODGED AND MIGRATED DOWN TO PATIENT'S HEART. PATIENT WAS STABLE POST PORT AND TUBING REMOVAL.
PORT TUBING BECAME DISLODGED AND MIGRATED DOWN TO PATIENT'S HEART. PATIENT WAS STABLE POST PORT AND TUBING REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102587 | POLYSITE IMPLANTABLE INFUSION PORTS | POLYSITE IMPLANTABLE INFUSION PORTS | LJT | PEROUSE MEDICAL | 4018PI | 23010086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male |