BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 4460705 · Received January 23, 2015

    Report

    Report Number
    2242352-2014-01426
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    December 30, 2014
    Report Date
    December 30, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR SOPS, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMITY RECORDED IN THE LOT HISTORY. INTERNAL COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BALLOON OF THE VASOVIEW 7 XBA RUPTURED. THE CASE WAS COMPLETED WITHOUT USING THE BALLOON, A REPLACEMENT DEVICE WAS NOT USED. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54039 VASOVIEW 7 XB ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR LLC VH-3200 25105768

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR