CERTAS INLIN VLV SPHN/UNIT CAT
Report
- Report Number
- 3013886523-2021-00586
- Event Type
- Injury
- Date Received
- January 7, 2022
- Date of Event
- November 11, 2021
- Report Date
- February 23, 2022
- Manufacturer
- INTEGRA LIFESCIENCES SWITZERLAND SAR
- Product Code
- JXG
- PMA / PMN Number
- K143111
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE CERTAS VALVE WAS RETURNED FOR EVALUATION: DHR - LOT 142447 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, A SMALL CUT/TEAR IN THE SILICONE HOUSING AROUND THE SIPHON GUARD. THE VALVE PASSED THE TESTS FOR PROGRAMING, OCCLUSION, LEAK, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE - AT THE TIME OF INVESTIGATION NO PROGRAMING ISSUES WERE NOTED. THE POSSIBLE ROOT CAUSE FOR THE PROGRAMING ISSUE REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM. THE ROOT CAUSE FOR THE TEAR/CUT IN THE SILICONE HOUSING ON THE SIPHON GUARD WAS DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING AS NOTED IN THE IFU, SILICONE HAS A LOW TEAR/CUT RESISTANCE, AT THE TIME OF INVESTIGATION NO LEAKAGE WAS NOTED FORM THIS CUT/TEAR.
A FACILITY REPORTED A CERTAS VALVE WAS IMPLANTED ON (B)(6) 2017, COULD NOT BE REPROGRAMMED AND WAS EXPLANTED ON (B)(6) 2021.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2623483 | CERTAS INLIN VLV SPHN/UNIT CAT | CERTAS PLUS W/ SG | JXG | INTEGRA LIFESCIENCES SWITZERLAND SAR | 142447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |