BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2151742 · Received July 6, 2011

    Report

    Report Number
    3005099803-2011-02326
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS HALF DEPLOYED AND WAS NOT RETURNED. THE YOKE, WHICH WAS STILL ATTACHED TO THE CONTROL WIRE, WAS THEN ACTUATED AND DEPLOYED. IT WAS ALSO NOTICED THAT THERE WAS A KINK IN THE CONTROL WIRE. THE REPORTED EVENT OF CLIP FAILED TO RELEASE WAS NOT ABLE TO BE CONFIRMED DUE TO THE CLIP ASSEMBLY NOT BEING RETURNED. HOWEVER, THE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE, AS EVIDENT OF THE KINK IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-001729 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, UPON ARRIVAL TO THE PROCEDURE ROOM, THE PATIENT HAD AN ULCER IN THE DUODENUM WHICH WAS ACTIVELY BLEEDING. THE SITE WAS CAUTERIZED AND INJECTED WITH EPINEPHRINE, THEN A CLIP WAS PLACED. THE BLEED HAD STOPPED, HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE DEVICE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE CLIP FROM THE TISSUE, BUT THIS LED TO FURTHER BLEEDING. THE CLIP WAS REMOVED ATTACHED TO THE DELIVERY SYSTEM, THEN ANOTHER ATTEMPT WAS MADE USING A NEW CLIP, BUT THE SAME ISSUE RECURRED. HOWEVER, NO TISSUE DAMAGE OR ADDITIONAL BLEEDING RESULTED FROM THE SECOND CLIP FAILING TO RELEASE. THE CLIP WAS REMOVED ATTACHED TO THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH A THIRD RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR