BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT VASO VIEW HEMOPRO

    MDR report key: 1022512 · Received March 31, 2008

    Report

    Report Number
    2953148-2008-00313
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RECEIVED WITH THE C-RING SPLIT (CRACKED) IN TWO PIECES. FROM THE INVESTIGATION, THE RETURNED C-RING WAS SUBJECTED TO A HEAT SOURCE LONG ENOUGH TO MELT AND SUBSEQUENTLY SPLIT THE C-RING INTO TWO PIECES DURING CLINICAL MANIPULATION. THE COMPLAINT IS CONFIRMED. A LHR 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 THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE C-RING CRACKED IN HALF, BROKE AWAY FROM THE C-RING HOLDER AND FELL IN THE PATIENT'S LEG. THE HARVESTER RETRIEVED THE C-RING USING THE HEMOPRO JAW THROUGH THE ORIGINAL INCISION. NO ADDITIONAL INCISION WAS DONE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASO VIEW HEMOPRO GEI GUIDANT CARDIAC SURGERY VH-3000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention