BEUDAMED
    FDA Adverse Event Death Summary report: N

    HORIZON SMALL WIDE 8" APPLIER

    MDR report key: 779838 · Received November 9, 2006

    Report

    Report Number
    1044475-2006-00019
    Event Type
    Death
    Date Received
    November 9, 2006
    Manufacturer
    WECK, TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS FOR THE APPLIERS WERE NOT REPORTED TO THE MANUFACTURING FACILITY. TELEFLEX MEDICAL IS STILL AWAITING FOR PRODUCT RETURN TO BEGIN INVESTIGATION AND TO DETERMINE LOT NUMBERS. AT THIS TIME, TELEFLEX MEDICAL IS UNABLE TO PERFORM A DEVICE HISTORY RECORD REVIEW WITHOUT INDENTIFICATION OF THE LOT NUMBER. IF THE APPLIERS ARE RECEIVED, A DHR REVIEW AND EVALUATION WILL BE PROVIDED. THE ACTUAL DEVICE INVOLVED IN DEATH WAS NOT SEGREGATED AT TIME OF EVENT, THEREFORE, AN EVALUATION WILL BE PERFORMED ON ALL RETURNED APPLIERS. SEVERAL ATTEMPTS HAVE BEEN MADE BY MEDICAL AFFAIRS TO OBTAIN ADDITIONAL INFORMATION REGARDING DEATH OF PATIENT WITH THE INSTITUTION WITHOUT SUCCESS. MEDICAL AFFAIRS THEN ASKED OUR MEDICAL CONSULTANT TO CONTACT THE INSTITUTION. MEDICAL CONSULTANT WAS ABLE TO GATHER THIS INFORMATION: CONSULTANT SPOKE WITH INSTITUTION'S EMPLOYEE. EMPLOYEE WAS NOT AT THE PROCEDURE, BUT BELIEVED THAT IT WAS A CABG AND THAT THE SAPHENOUS VEIN WAS USED AS A CONDUIT. HE STATED THAT DR. HAS HAD ISSUES IN THE PAST WITH CLIPS SCISSORING. EMPLOYEE STATED THAT PATIENT EXPERIENCED HEMORRHAGING POST-OPERATIVELY AND WAS RETURNED TO THE OPERATING ROOM. IT WAS REPORTED TO EMPLOYEE THAT THE SURGEON REPORTED THAT THE CLIP OR CLIPS ON A BRANCH OF THE SAPHENOUS VEIN CONDUIT HAD COME OFF ACCOUNTING FOR THE BLEEDING. PATIENT EXPIRED IN THE OR SHORTLY THEREAFTER.

    Description of Event or Problem · 1

    TELEFLEX MEDICAL RECEIVED INTIAL INFORMATION THAT THE INSTITUTION WAS EXPERIENCING SCISSORING OF CLIPS DURING USE. IT WAS THEN DISCOVERED THAT THE FACILITY HAD EXPERIENCED A DEATH DUE TO A DROPPED CLIP OFF THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON SMALL WIDE 8" APPLIER LIGATION CLIP APPLIER FZP WECK, TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death