BEUDAMED
    FDA Adverse Event Death Summary report: N

    WECK HEM-O-LOK CLIPS

    MDR report key: 1302693 · Received January 27, 2009

    Report

    Report Number
    3003898360-2009-00007
    Event Type
    Death
    Date Received
    January 27, 2009
    Date of Event
    October 28, 2009
    Report Date
    January 12, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TELEFLEX MEDICAL STATES IN THE IFU THAT HEM-O-LOK LIGATING CLIPS ARE CONTRAINDICATED FOR USE IN LIGATING THE RENAL ARTERY DURING LAPAROSCOPIC DONOR NEPHRECTOMIES. THE HOSPITAL DID ACKNOWLEDGE RECEIPT OF NOTIFICATION FOR CONTRAINDICATION. THERE WILL BE NO SAMPLE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE INCIDENT WAS REPORTED AS: APPROXIMATELY 8 HOURS POST-OP, A MALE DONOR NEPHRECTOMY DEVELOPED DIFFICULTY BREATHING AND BECAME UNRESPONSIVE. HE WAS RETURNED TO SURGERY WHERE AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND INTRA-PERITONEAL BLEEDING WAS ENCOUNTERED AND EVACUATED FROM THE ABDOMINAL CAVITY. IT WAS NOTED THE CLIP THAT HAD BEEN PLACED ON THE RENAL ARTERY STUMP DURING THE NEPHRECTOMY WAS NOT VISIBLE. A 1.5 CM TEAR WAS NOTED AT THE AORTA, WHICH WAS CLAMPED AND REPAIRED. THE RENAL ARTERY APPEARED THIN AND FRIABLE. THE PATIENT DEVELOPED DIC AND EXPIRED. THE HOSPITAL ADMITS RECEIVING NOTICE OF CONTRAINDICATION FOR USE OF THIS CLIP IN A LIVING DONOR NEPHRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK CLIPS LIGATING CLIPS FZP TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death