BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB

    MDR report key: 3131099 · Received May 23, 2013

    Report

    Report Number
    2242352-2013-00488
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7 XB SHORT PORT BTT BALLOON RUPTURED. NOTHING FELL INTO THE PATIENT AND NO INTERVENTION WAS REQUIRED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230457 VASOVIEW 7 XB ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR VH-3200 25069329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other