BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2873829 · Received December 14, 2012

    Report

    Report Number
    3005099803-2012-05667
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    September 7, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED WITH A KINK IN THE CONTROL WIRE, THE TABS PARTIALLY OPENED, AND THE PRONGS BENT. FUNCTIONALLY, WHEN THE DEVICE WAS ACTUATED AND DEPLOYED, THE CLIP ASSEMBLY SEPARATED, BUT ONE OF THE PRONGS DETACHED; HOWEVER, TWO DISTINCTIVE CLICKS WERE HEARD DURING DEPLOYMENT. ADDITIONALLY, THE SLIDER COVER WAS FOUND TO BE BROKEN AND THE CROSS PIN WAS DETACHED FROM THE SLIDER. THE OVERSHEATH, WHICH RETURNED ACCORDIONED NEAR THE SHEATH GRIP, HAD APPROXIMATELY 10CM CUT FROM ITS DISTAL END. THE REPORTED EVENT OF CLIP WON'T OPEN WAS NOT ABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURN DEVICE. HOWEVER, THE EVALUATION REVEALED THAT APPROXIMATELY 10CM WAS CUT AWAY FROM THE DISTAL END OF THE OVERSHEATH. BASED ON THIS FINDING, THIS EVENT IS NOW CONSIDERED MDR-REPORTABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ESD (ENDOSCOPIC SUBMUCOSAL DISSECTION) PROCEDURE FOR RECTAL POLYPS PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE TO THE TARGET LESION, THE PHYSICIAN FOUND THAT THE CLIP ASSEMBLY WAS NOT ABLE TO BE OPENED. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. PRIOR TO USE, NO DAMAGE WAS NOTED TO THE DEVICE OR ITS PACKAGING. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT CONDITION WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; THE OVERSHEATH WAS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000233C2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR