BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2822263 · Received November 7, 2012

    Report

    Report Number
    3005099803-2012-05246
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN. HOWEVER, THE PATIENT WAS BORN SOMETIME IN (B)(6). (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO SEPARATE FROM CATHETER. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. A KINK WAS NOTICED IN THE CONTROL WIRE. THE COIL WAS CUT AT THE BUSHING, AND THE CLIP ASSEMBLY WAS SMASHED. A FUNCTIONAL EVALUATION OF THE DEVICE FOUND THAT THE PRONGS COULD NOT BE OPENED OR CLOSED, AND THE CLIP ASSEMBLY COULD NOT BE DEPLOYED. THE SHEATH GRIP AND OVER SHEATH WERE NOT RETURNED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CLIP ASSEMBLY FAILED TO RELEASE FROM THE DELIVERY CATHETER, AND THAT THE CLIP WOULDN'T OPEN/CLOSE. THE EVALUATION FOUND THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING WHICH PREVENTED ITS SEPARATION FROM THE DELIVERY CATHETER. THE EVENT MAY HAVE OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE AS IS EVIDENT BY THE KINK IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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 COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS NOT ABLE TO BE DEPLOYED AND REMAINED STUCK IN THE OPEN POSITION. REPORTEDLY, THE CLIP WAS NOT ABLE TO BE RELEASED FROM THE DELIVERY CATHETER SO THE SCOPE AND RESOLUTION CLIP DEVICE WERE REMOVED IN TANDEM, AND THEN THE DISTAL END OF THE DEVICE WAS CUT OFF USING WIRE CUTTERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS NOT ABLE TO BE DEPLOYED AND REMAINED STUCK IN THE OPEN POSITION. REPORTEDLY, THE CLIP WAS NOT ABLE TO BE RELEASED FROM THE DELIVERY CATHETER SO THE SCOPE AND RESOLUTION CLIP DEVICE WERE REMOVED IN TANDEM, AND THEN THE DISTAL END OF THE DEVICE WAS CUT OFF USING WIRE CUTTERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000326C3

    Patients

    Seq Age Sex Outcome Treatment
    1