BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2130143 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-02086
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. A KINK WAS FOUND IN THE CONTROL WIRE, WHICH WAS NOT ATTACHED TO THE CLIP ASSEMBLY. THE CLIP ASSEMBLY COULD NOT BE DEPLOYED AND THE PRONGS COULD NEITHER BE OPENED NOR CLOSED. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT OF A POOR BITE; THE COMPLAINT WAS NOT CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS CONSIDERED TO BE OPERATIONAL CONTEXT, AS THE PRODUCT MET DESIGN AND MANUFACTURE SPECIFICATIONS, BUT PERFORMANCE WAS LIMITED BY ANATOMICAL/PROCEDURAL FACTORS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01613, 3005099803-2011-01616, 3005099803-2011-01617 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGEAL HEMOSTASIS PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A RESOLUTION CLIP WAS POSITIONED WITHIN THE PATIENT'S ESOPHAGUS AND CLOSED ONTO THE TISSUE; HOWEVER, AFTER THE CLIP WAS RELEASED FROM THE CATHETER, IT DETACHED AND FELL INTO THE PATIENT IN A CLOSED STATE. ANOTHER RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01613) WAS POSITIONED WITHIN THE PATIENT'S ESOPHAGUS AND CLOSED ONTO THE TISSUE; HOWEVER, AFTER THE CLIP WAS RELEASED FROM THE CATHETER, IT REOPENED AND FELL INTO THE PATIENT. THE SAME ISSUE OCCURRED FOR TWO ADDITIONAL RESOLUTION CLIPS (MANUFACTURER REPORT #'S 3005099803-2011-01616 AND 3005099803-2011-01617) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: CLIP FAILED TO RELEASE FROM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 11011704C2

    Patients

    Seq Age Sex Outcome Treatment
    1