BEUDAMED
    FDA Adverse Event Death Summary report: N

    WECK HEMOCLIP TRADITIONAL LIGATION CLIP

    MDR report key: 745317 · Received May 17, 2006

    Report

    Report Number
    1044475-2006-00012
    Event Type
    Death
    Date Received
    May 17, 2006
    Date of Event
    March 4, 2006
    Report Date
    May 17, 2006
    Manufacturer
    WECK, TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    na
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL CLIPS USED IN THE PROCEDURE WERE NOT SAVED. THE APPLIER(S) USED TO APPLY THE CLIPS WAS NOT IDENTIFIED. THE LOT NUMBER(S) OF THE CLIPS USED IN THE PROCEDURE WERE NOT IDENTIFIED. A SIX MONTH CUSTOMER SALES HISTORY, FOR CATALOG NUMBER 523700, WAS PERFORMED AND IDENTIFIED THE PURCHASE OF THREE DIFFERENT LOT NUMBERS. THESE LOT NUMBERS INCLUDE: 2217806, 2217807, AND 2217808. A REVIEW WAS PERFORMED FOR THE IDENTIFIED LOT NUMBERS FROM THE PURCHASED SALES HISTORY. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS IN THESE FILES. NUMEROUS ATTEMPTS HAVE BEEN MADE TO ACQUIRE ADD'L INFO REGARDING THE INCIDENT: NO ADD'L INFO HAS BEEN PROVIDED. IF ADD'L INFO IS MADE AVAILABLE, TELEFLEX MEDICAL WILL SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    PER RECEIVED MEDWATCH FORM FILED BY USER FACILITY: EVENT DESC: PT HAD ROUTINE UNEVENTFUL CABG. POST-OP, EXCESSIVE BLEEDING WAS IDENTIFIED. PT COULD NOT BE STABILIZED, SUFFERED CARDIAC ARREST BEFORE SHE COULD BE RETURNED TO THE OR FOR EXPLORATORY SURGERY. REQUIRED CPR-CHEST OPENED TO FIND WECK HEMOCLIPS HAD LOOSENED, FALLEN OFF VEIN GRAFT. UNABLE TO BE STABILIZED. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOCLIP TRADITIONAL LIGATION CLIP MEDIUM TITANIUM LIGATION CLIP FZP WECK, TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death