BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSV II

    MDR report key: 11971548 · Received June 9, 2021

    Report

    Report Number
    9612007-2021-00026
    Event Type
    Injury
    Date Received
    June 9, 2021
    Report Date
    August 6, 2021
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K971799
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE OSV II VALVE (909712) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) ¿ THE DHR WAS REVIEWED BUT DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. FAILURE ANALYSIS -THE VALVE WAS RECEIVED WITH THE DRAINAGE CATHETER CUT AT THE LEVEL OF THE VALVE HOUSING. THE RETURNED VALVE PASSED PATENCY TEST WITH WATER. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED NO ANOMALY. THE VALVE WAS PRESSURE/FLOW TESTED AND FOUND OUT OF SPECIFICATIONS. THE VALVE MECHANISM WAS REMOVED FROM ITS SILICONE ELASTOMER HOUSING, OPENED, AND INSPECTED UNDER MAGNIFICATION: RESIDUE WAS FOUND BETWEEN THE PIN AND THE SEAT. THE COMPLAINT IS VERIFIED, THE VALVE AS RECEIVED IS OUT OF SPECIFICATION, BECAUSE OF RESIDUES BLOCKED IN THE VALVE MECHANISM AND IMPAIRING THE VALVE FUNCTIONING. ROOT CAUSE - THE COMPLAINT IS VERIFIED. THE VALVE AS RECEIVED IS OUT OF SPECIFICATION, BECAUSE OF RESIDUES BLOCKED IN THE VALVE MECHANISM AND IMPAIRING THE VALVE FUNCTIONING. THIS VALVE LOT 212048 SN (B)(6) WAS TESTED WITHIN SPECIFICATION AT TIME OF MANUFACTURING AS SHOWN ON THE DEVICE HISTORY RECORDS. IT IS POSSIBLE THAT SOME DEBRIS WERE RELEASED DURING THE VALVE IMPLANTATION AND MIGRATED IN THE VALVE MECHANISM. THE INSTRUCTIONS FOR USE (BL515010-REV04) CAUTION TO ¿CONNECT A SYRINGE WITH THE PROVIDED LUER CONNECTOR TO THE DRAINAGE CATHETER AND RINSE THE SYSTEM BY GENTLY ASPIRATING 2 TO 3 ML OF CSF TO ELIMINATE POSSIBLE DEBRIS AND PURGE AIR.¿

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE OSV II VALVE (909712) WAS IMPLANTED IN A PATIENT, AND AFTER A CHECK ON THE PATIENT WITH SCANNER, THE SURGEON OBSERVED THAT THE PATIENT'S VENTRICLES WAS COLLAPSED. THE VALVE DID NOT WORK, AND A REVISION PROCEDURE WAS REQUIRED. THE FACILITY KEPT THE VALVE FOR EVALUATION TO ASCERTAIN THE REASON WHY THE VALVE DID NOT WORK. NO DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867512 OSV II OSV II JXG INTEGRA NEUROSCICENCS IMPLANTS SA

    Patients

    Seq Age Sex Outcome Treatment
    1