BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASO VIEW HEMOPRO

    MDR report key: 1063670 · Received June 20, 2008

    Report

    Report Number
    2953148-2008-00617
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LHR REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO C-RING WAS CRACKED IN HALF DOWN THE MIDDLE WHEN THEY PUSHED THE C-RING OUT IN THE PT'S LEG. THE C-RING DID NOT BREAK OFF FROM THE SCOPE WASH TUBING OR THE C-RING SLIDER. NO PIECES NEEDED TO BE RETRIEVED FROM THE PT. 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 GUIDANT VASO VIEW HEMOPRO GEI GUIDANT CARDIAC SURGERY VH-3000 8040171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA