BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1934111 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05252
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED, AS THE CONTROL WIRE WAS SEPARATED PER DESIGN, AND WAS RETURNED INSIDE THE OVER SHEATH. IT IS PROBABLE THAT THE FAILURE TO RELEASE THE CLIP FROM THE DELIVERY CATHETER RESULTED FROM ANATOMICAL OR PROCEDURE FACTORS ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR LOT #10092407C2.

    Additional Manufacturer Narrative · 1

    (B)(4):ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP CLOSED ONTO THE TISSUE AND THE NURSE ATTEMPTED TO DEPLOY IT; HOWEVER, THE CLIP WOULD NOT DETACH FROM THE DELIVERY CATHETER. A SECOND RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP CLOSED ONTO THE TISSUE AND THE NURSE ATTEMPTED TO DEPLOY IT; HOWEVER, THE CLIP WOULD NOT DETACH FROM THE DELIVERY CATHETER. A SECOND RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 10092407C2

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR