BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 1811276 · Received August 17, 2010

    Report

    Report Number
    1811276
    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 SURGEON WAS USING THE RESOLUTION CLIP DURING A PROCEDURE. THE SHEATH WOULD NOT RETRACT AFTER THE CLIP WAS DEPLOYED. IT WOULD PARTIALLY RETRACT, BUT NOT COMPLETELY. STAFF OBTAINED ANOTHER CLIP, BUT IT ALSO DID NOT WORK. THE PATIENT HAD NO ILL EFFECTS. BLEEDING THAT WAS PRESENT RESOLVED AFTER WASHING THE SITE WITH SALINE. THE PHYSICIAN & STAFF INVOLVED IN THE EVENT ARE VERY EXPERIENCED IN THE PROCEDURE AND HAVE USED THIS EQUIPMENT MANY TIMES IN THE PAST.====================== 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 * 10032903C2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR