BEUDAMED
    FDA Adverse Event Death Summary report: N

    HORIZON APPLIER LARGE APPLIER 11" CURVED

    MDR report key: 2133373 · Received June 15, 2011

    Report

    Report Number
    1044475-2011-00066
    Event Type
    Death
    Date Received
    June 15, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO DEVICE SAMPLE AVAILABLE FOR INVESTIGATION. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    INFORMATION OBTAINED FROM MEDWATCH AND RISK MANAGER. COMPLAINT ALLEGES: PATIENT HAD A KIDNEY TRANSPLANT ON (B)(6) 2011, WHICH FAILED. ON (B)(6) 2011, PATIENT HAD THE REJECTED KIDNEY REMOVED. PATIENT THEN EXHIBITED SYMPTOMS OF HYPOVOLEMIA SEVEN HOURS POST-OP AND RETURNED TO THE OPERATING ROOM. TITANIUM LIGATING CLIPS WERE USED ON THE RENAL ARTERY DURING THE ALLOGRAFT NEPHRECTOMY SURGERY. PATIENT WAS REOPENED POST-OPERATIVELY AND THE RENAL ARTERY WAS OPEN AND ACTIVELY BLEEDING. THE PATIENT EXPIRED IN THE OPERATING ROOM. TWO APPLIERS HAD BEEN USED: ONE LARGE AND ONE MEDIUM. TWO SIZES OF CLIPS WERE USED: MEDIUM AND LARGE. IT IS UNCLEAR WHICH SIZE CLIP WAS USED ON THE RENAL ARTERY. THERE ARE NO SAMPLES AVAILABLE FOR INVESTIGATION. NO AUTOPSY WAS PERFORMED PER THE RISK MANAGER. REFERENCE MDR# FOR OTHER CLIPS AND APPLIER: MDR# 3003898360-2011-00277, MDR# 3003898360-2011-00278, MDR# 1044475-2011-00062.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON APPLIER LARGE APPLIER 11" CURVED LIGATING CLIP APPLIER FZP TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death HORIZON TITANIUM MEDIUM CLIP, (B)(4)| HORIZON MEDIUM APPLIER CURVED 11", (B)(4)| HORIZON TITANIUM LARGE CLIP, (B)(4)