BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3211216 · Received July 8, 2013

    Report

    Report Number
    3005099803-2013-05746
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. EVALUATION FINDING OF OVERSHEATH CUT. A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED WITH THE CLIP ASSEMBLY FULLY DEPLOYED AND NOT RETURNED. A KINK WAS PRESENT IN BOTH THE CONTROL WIRE AND COIL. FURTHERMORE, APPROXIMATELY 2 INCHES OF THE DISTAL END OF THE OVERSHEATH WAS CUT OFF AND NOT RETURNED. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE ¿CLIP ASSEMBLY UNABLE TO CLOSE", COULD NOT BE CONFIRMED. HOWEVER, IT IS LIKELY THAT THE DIFFICULTIES EXPERIENCED DURING DEPLOYMENT WERE DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, TWO RESOLUTION CLIPS HAD BEEN SUCCESSFULLY DEPLOYED ON THE TARGET SITE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ATTACH A THIRD RESOLUTION CLIP; HOWEVER THE CLIP WOULD NOT CLOSE ONTO TISSUE. THE DEVICE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THE FIRST TWO RESOLUTION CLIPS AND THERE WAS NO NEED FOR A THIRD CLIP. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310545 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000447C3

    Patients

    Seq Age Sex Outcome Treatment
    1