BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM ACCESSORY PACK

    MDR report key: 1516845 · Received October 22, 2009

    Report

    Report Number
    3006262933-2009-01309
    Event Type
    Malfunction
    Date Received
    October 22, 2009
    Date of Event
    September 23, 2009
    Report Date
    October 9, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: BASED ON THE REPORTED COMPLAINT AND THE VISUAL ANALYSIS, THIS IS A CASE OF THE VALVE BACKING OUT OF THE LUER FITTING CAUSING THE BALLOON TO DEFLATE DUE TO A DEFECTIVE VALVE SUBASSEMBLY. THE REPORTED FAILURE "SHORT PORT BTT BLACK INFLATION VALVE DISLODGED" WAS CONFIRMED. (B) (4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SHORT PORT BTT BLACK INFLATION VALVE DISLODGED (POPPED OUT) WHEN STAFF PUSHED IN THE SYRINGE, FILLED THE BALLOON WITH AIR THEN PULLED OUT THE SYRINGE. THE NEXT THREE ACCESSORIES SHORT PORTS BTT WERE USED WITH THE SAME RESULTS. THE STAFF CONTINUED TO OPEN ACCESSORY KIT UNTIL THEY GOT A GOOD ONE TO USE AND THE PROCEDURE WAS COMPLETED. THE HOSP DID NOT REPORT ANY PT COMPLICATIONS. THIS REPORT IS FOR THE THIRD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM ACCESSORY PACK GEI MAQUET CARDIOVASCULAR VH-2004 9072871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA