BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1570602 · Received December 22, 2009

    Report

    Report Number
    3006262933-2009-01738
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Report Date
    December 4, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT # 9052771 THAT WAS PROVIDED FOR THIS EVENT DOES NOT EXIST IN MAQUET'S SYSTEM. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SHORT PORT BTT BLACK INFLATION VALVE DISLODGED HALF WAY, BUT DID COMPLETELY POP OUT. AS A RESULT, THE BALLOON COULD NOT REMAIN INFLATED, CAUSING THE TUNNEL TO COLLAPSE. A REPLACEMENT UNIT WAS USED FROM AN ACCESSORY KIT TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 9052771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA