BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2091733 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01729
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    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.THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND WAS NOT RETURNED. IN ADDITION, 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 BY THE KINK IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02326 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS 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 AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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 Required Intervention