PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/19
Report
- Report Number
- 3004721439-2019-00120
- Event Type
- Injury
- Date Received
- May 14, 2019
- Report Date
- June 19, 2019
- Manufacturer
- CHRISTOPH MIETHKE GMBH & CO. KG
- Product Code
- JXG
- PMA / PMN Number
- K011030
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044 WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.
AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044 INVESTIGATION: VISUAL INSPECTION: NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVES WERE DETECTED DURING THE VISUAL INSPECTION. IT WAS OBSERVED THAT THE PAEDIGAV WAS CONNECTED TO A PROGAV 2.0 SHUNT SYSTEM WITH CONTROL RESERVOIR (RM 3193). IT WAS ADDITIONAL NOTED, THAT THE RESERVOIR WAS NOT PROPERLY CONNECTED TO THE VENTRICULAR CATHETER. PERMEABILITY TEST: A PERMEABILITY TEST HAS INDICATED THAT THE VALVE HAS A BLOCKAGE. IT WAS FURTHER SHOWN THAT THE CATHETERS WERE PERMEABLE. ADJUSTMENT TEST: THIS IS A FIXED PRESSURE VALVE. AN ADJUSTMENT TEST IS NOT APPLICABLE. BRAKING FORCE AND BRAKE FUNCTION TEST: THIS IS A FIXED PRESSURE VALVE. A BREAKING FORCE AND BREAK FUNCTION TEST IS NOT APPLICABLE. RESULTS: IT SHOULD BE NOTED THAT THE VALVE WAS RECEIVED DRY (I.E. NOT SUBMERSED IN LIQUID AS RECOMMENDED) THE INVESTIGATION OF DRY ITEMS IS NOT SIGNIFICANT DUE TO THE AFFECT DRY DEPOSITS OF LIQUOR AND BLOOD CAN HAVE ON PRODUCT PERFORMANCE. IN SPITE OF THIS, WE HAVE INVESTIGATED THE VALVE TO THE BEST OF OUR ABILITIES. FIRST WE PERFORMED A VISUAL INSPECTION OF THE PAEDIGAV VALVE. NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE WERE DETECTED DURING THE VISUAL INSPECTION. NEXT WE TESTED THE PERMEABILITY OF THE VALVE. THE VALVE WAS SHOWN TO HAVE A BLOCKAGE. THE CATHETERS WERE SHOWN TO BE PERMEABLE. FINALLY WE HAVE DISMANTLED THE VALVE. INSIDE THE VALVE WE HAVE FOUND BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE CONFIRM THE PRESENCE OF OCCLUSION IN THE VALVE, LIKELY DUE TO THE DEPOSITS OBSERVED INSIDE THE VALVE. AS DESCRIBED IN OUR LITERATURE, THE PROBLEM ENCOUNTERED IS ONE OF THE KNOWN, INEVITABLE RISKS OF HC-THERAPY BY SHUNT IMPLANTS. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FIN INSPECTION WHEN RELEASE FROM CHRISTOPH MIETHKE GMBH & CO. KG. ASSOCIATED MEDWATCH: 3004721439-2019-00119
AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT INFECTION AFTER IMPLANTATION. FX431-T AND FV303T SHUNTS WERE USED IN COMBINATION. PATIENTS WERE IMPLANTED SHUNTS FOR VENTRICULOPERITONEAL DRAINAGE. AFTER IMPLANTATION, INFECTION OCCURRED IN THE PATIENT'S BRAIN. THEN WITHDREW THE SHUNT PIPE.
IT WAS REPORTED THAT INFECTION AFTER IMPLANTATION. FX431-T AND FV303T SHUNTS WERE USED IN COMBINATION. PATIENTS WERE IMPLANTED SHUNTS FOR VENTRICULOPERITONEAL DRAINAGE. AFTER IMPLANTATION, INFECTION OCCURRED IN THE PATIENT'S BRAIN. THEN WITHDREW THE SHUNT PIPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402576 | PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/19 | HYDROCEPHALUS MANAGEMENT | JXG | CHRISTOPH MIETHKE GMBH & CO. KG | FV303T | 20037066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |