BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 3763578 · Received April 16, 2014

    Report

    Report Number
    MW5035726
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    HCH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH NON-STEMI MI AND AN INTERMITTENT GI BLEED, WITH GUAIAC POSITIVE STOOL. THE PT UNDERWENT AN URGENT ENDOSCOPY UNDER GENERAL ANESTHESIA AS H/H DROPPED. THE ENDOSCOPY REVEALED EVIDENCE OF AN OOZING DUODENAL ULCER. THE PHYSICIAN DECIDED TO CLIP THE BLEEDERS. WHEN THE CLIP OPENED, THE TIP FELL OFF. ANOTHER DEVICE HAD TO BE OBTAINED, THE CLIPS WERE APPLIED AND THE PROCEDURE COMPLETED. ALTHOUGH THERE WAS NO HARM TO THE PT, THE DEVICE WAS DEFECTIVE RESULTING IN A DELAY (INTER-PROCEDURAL WITH GENERAL ANESTHESIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233160 BOSTON SCIENTIFIC RESOLUTION CLIP HCH BOSTON SCIENTIFIC M00622610 ML000626C3

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention