POLYSITE
Report
- Report Number
- 2245270-2024-00016
- Event Type
- Injury
- Date Received
- February 9, 2024
- Date of Event
- January 11, 2024
- Report Date
- March 15, 2024
- Manufacturer
- PEROUSE MEDICAL
- Product Code
- LJT
- UDI-DI
- 03661234017584
- PMA / PMN Number
- K122834
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
WE CONTACTED THE CUSTOMER AND ASKED FOR MORE DETAILS ABOUT THE INCIDENT. THE CUSTOMER HAS INFORMED US THAT THERE IS NO DEFECTIVE PRODUCT TO RETURN, AND NO FURTHER DETAILS CAN BE PROVIDED ABOUT THE INSERTION SITE OR THE DEVICE PROBLEM AND WHY THE PORT HAD TO BE REMOVED, OTHER THAN AS STATED IN THE INCIDENT DESCRIPTION. AS A RESULT, THIS COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE OF THE ISSUE COULD NOT BE PRECISELY DETERMINED. THE MOST LIKELY HYPOTHESIS THAT COULD EXPLAIN THE EXTERNALIZATION PHENOMENON FROM THE IMPLANTABLE PORT COULD BE : THE USE OF AN IMPLANTABLE PORT NOT ADAPTED TO THE PATIENT'S MORPHOLOGY (DIMENSION (TOO LARGE), MATERIAL, INDICATION. IMPLANTABLE PORT LOCATED LESS THAN 1 CM FROM THE SKIN. WEIGHT LOSS OF THE PATIENT. THE WEAKENING OF THE PATIENT'S SKIN BY CHEMO PRODUCTS. UNFORTUNATELY, WITHOUT ADDITIONAL INFORMATION REGARDING OUR INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THESE HYPOTHESES. THE REVIEW OF THE MANUFACTURING BATCH RECORD OF THE POLYSITE (B)(6) IMPLANTABLE PORT FINAL PRODUCT (LOT 22090085) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF THE INCIDENT. 100% VISUAL INSPECTION IS PERFORMED ON PACKAGING INTEGRITY AND SEAL CONFORMITY DURING THE PRODUCTION PROCESS. IN ADDITION, THE ETHYLENE OXIDE STERILIZATION CYCLE IN FORCE FOR THIS FAMILY HAS BEEN VALIDATED PER CURRENT REGULATIONS AND STANDARDS. THE REVIEW OF THE STERILIZATION FILE REFERENCE ST22100 IS COMPLIANT WITH THE SPECIFICATIONS. PEROUSE MEDICAL HAS BEEN INFORMED OF TWO OTHER INCIDENTS INVOLVING LOT 22090085, A SIMILAR INCIDENT REPORTED BY THE SAME HOSPITAL CENTER AND ANOTHER FOR A DIFFERENT DEFECT. MOREOVER, PEROUSE MEDICAL HAS NOT BEEN INFORMED OF INFECTION IMPLYING THE BATCH 22090085 AND FINISHED PRODUCTS INCLUDED IN THE STERILIZATION FILE REFERENCE ST22100. PEROUSE MEDICAL HAS NOT RECORDED SIMILAR INCIDENTS OF PORT EXTERNALIZATION BETWEEN 2020 AND 2023 ACROSS ALL OF ITS IMPLANTABLE CATHETER PORTS. ON THE OTHER HAND, WE HAVE BEEN INFORMED OF FOUR SIMILAR INCIDENTS IN 2024 OCCURRING IN THE SAME HOSPITAL CENTER. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE AND FURTHER INFORMATION THIS COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. ADDITIONALLY, WITHOUT ADDITIONAL INFORMATION ABOUT THE INFECTION ENCOUNTERED, WE CANNOT DETERMINE ITS ORIGIN. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT. VYGON WILL CONTINUE TO MONITOR THIS ISSUE AND ESCALATE AS APPROPRIATE.
ALTHOUGH THE MALFUNCTIONING DEVICE WAS NOT RETURNED TO VYGON, THE DETAILS OF THE MALFUNCTION WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.
PORT SITE IS OPEN/INFECTED. PORT WAS REMOVED.
PORT SITE IS OPEN/INFECTED. PORT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59889 | POLYSITE | POLYSITE PRESSURE INJECTABLE IMPLANTABLE PORT | LJT | PEROUSE MEDICAL | 3017SPI | 22090085 | 03661234017584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |