BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 1811280 · Received August 17, 2010

    Report

    Report Number
    1811280
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO STOP BLEEDING BY USING THE RESOLUTION CLIP. TWO OTHER ATTEMPTS WITH TWO OTHER DEVICES FROM THE SAME LOT NUMBER HAD FAILED. STAFF OBTAINED THIS DEVICE (DIFFERENT LOT #) AND THE DOCTOR TRIED AGAIN TO USE THE CLIP. HOWEVER, THE CLIP DID NOT FUNCTION WHEN THE DOCTOR TRIED TO DEPLOY IT. THE CLIP WAS NOT USED. THE BLEEDING SITE WAS RINSED WITH SALINE & THE BLEEDING SUBSIDED ON ITS OWN. THERE WAS NO PATIENT HARM.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THEY DO NOT KNOW.====================== MANUFACTURER RESPONSE FOR CLIP, RESOLUTION CLIP======================WE ARE AWAITING THE MANUFACTURER'S REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIP, IMPLANTABLE FZP BOSTON SCIENTIFIC * 10030801C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR