BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM ACCESSORY PACK

    MDR report key: 1193197 · Received October 7, 2008

    Report

    Report Number
    2953148-2008-00834
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NO NON-CONFORMITIES WERE FOUND DURING THE VISUAL INSPECTION OF THE NON-INFLATED BALLOON. THE BALLOON WAS INFLATED TO 35 CC OF AIR AND INSPECTED. FROM THE SIDE VIEW, THE BALLOON DID NOT APPEAR TO BE MALFORMED (ASYMMETRICAL) IN SHAPE. THE CONCENTRICITY OF THE BALLOON WAS MEASURED AND MET THE MINIMUM OD SPECIFICATION. THE REPORTED FAILURE WAS NOT CONFIRMED. A LOT HISTORY RECORD REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SHORT PORT BALLOON WAS MALFORMED. IT WAS ASYMMETRICAL. A REPLACEMENT UNIT WAS USED 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 ENDOSCOPIC VESSEL HARVESTING SYSTEM ACCESSORY PACK GEI GUIDANT CARDIAC SURGERY VH-2004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA