BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCLIP

    MDR report key: 704 · Received June 2, 1992

    Report

    Report Number
    704
    Event Type
    Death
    Date Received
    June 2, 1992
    Date of Event
    April 21, 1992
    Report Date
    May 10, 1992
    Manufacturer
    EDWARD WECK, INC.
    Product Code
    MCH
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS 1-1/2 HOURS AFTER CABG ON 4/21/92, WHEN CONDITION BEGAN TO DETERIORATE. BLEEDING AND CARDIAC TAMPONADE DEVELOPED. WHEN CHEST WAS REOPENING, TWO HEMOCLIPS, PLACED DURING SURGERY, WERE FOUND AT CIRCUMFLEX VEIN GRAFT ALONGSIDE A BRANCH. ACCORDING TO THE ATTENDING PHYSICIAN, THE HEMOCLIPS WERE CLOSED BUT NO LONGER ON THE GRAFT. INTERNAL CHEST RESUSCITATION WAS INITIATED, BUT THE PATIENT EXPIRED. ATTENDING PHYSICIAN WAS UNAVAILABLE FROM 4/21/92 THROUGH 5/8/92. EVENT VERIFICATION WAS CONDUCTED AND COMPLETED UPON THE ATTENDING PHYSICIANS RETURN ON 5/8/92DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, UNANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCLIP Implant LIGATING CLIP MCH EDWARD WECK, INC. 515 1L0643

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death