BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3964598 · Received May 30, 2014

    Report

    Report Number
    2242352-2014-00628
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE SILICONE LAYER OF THE BALLOON HAD RUPTURED. EACH BTT UNDER GOES A FULL INFLATION AND DEFLATION INSPECTION PRIOR TO DISTRIBUTION. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL CORRECTIVE ACTION (B)(4) ISSUED FOR THIS FAILURE MODE. INTERNAL COMPLAINT NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TROCAR BALLOON POPPED ON THE VASOVIEW HEMOPRO 2. THE AMOUNT OF PRESSURE WAS NOT PROVIDED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317967 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25095210

    Patients

    Seq Age Sex Outcome Treatment
    1