BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2822517 · Received November 7, 2012

    Report

    Report Number
    3005099803-2012-05101
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 15, 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
    NC, 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. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO SEPARATE FROM CATHETER. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05099, 3005099803-2012-05100, AND 3005099803-2012-05101 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE WITHIN THE DUODENUM PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP DEVICE (MFR # 3005099803-2012-05099) WAS LOCKED AND DEPLOYED ONTO THE TARGET TISSUE, HOWEVER, IT FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE CLIP ASSEMBLY WAS PULLED FROM THE TISSUE WHICH CAUSED ADDITIONAL, BUT "NOT EXCESSIVE", BLEEDING. TWO MORE RESOLUTION CLIP DEVICES (MFR # 3005099803-2012-05100 AND 3005099803-2012-05101) WERE THEN USED, BUT THE SAME ISSUE OCCURRED; AFTER DEPLOYMENT, THE CLIPS FAILED TO RELEASE FROM THE DELIVERY CATHETER. IT IS NOT CURRENTLY KNOWN IF REMOVAL OF THESE TWO CLIP ASSEMBLIES LED TO ADDITIONAL BLEEDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A FOURTH RESOLUTION CLIP DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1