BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 CLIP

    MDR report key: 10276008 · Received July 15, 2020

    Report

    Report Number
    3005099803-2020-02773
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 18, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729875642
    PMA / PMN Number
    K151802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE 2906 CAPTURES THE REPORTABLE EVENT OF CLIP FAILED TO RELEASE FROM THE CATHETER. BLOCK H10: INVESTIGATION RESULTS THE RETURNED RESOLUTION 360 CLIP DEVICE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE CLIP ASSEMBLY WAS RETURNED ATTACHED TO THE DEVICE. MICROSCOPE EXAMINATION WAS PERFORMED AND THE CLIP ASSEMBLY HAD ONE OF ITS ARMS ACTIVATED, AS THE CLIP WING WAS INSIDE OF THE CAPSULE WINDOW. IT WAS OBSERVED THAT THE TENSION BREAKER HAD SIGNS OF WEAR WHICH COULD BE CAUSED DUE TO SOME FRICTION BETWEEN THE CLIP JAWS. FUNCTIONAL EXAMINATION WAS NOT PERFORMED DUE TO THE PRIMARY FAILURE OBSERVED IN THE DEVICE. ADDITIONALLY, X-RAY ANALYSIS WAS PERFORMED, AND IT WAS POSSIBLE TO OBSERVE THAT ONE ARM WAS DETACHED FROM THE YOKE. DIMENSIONAL EXAMINATION WAS PERFORMED BETWEEN THE HOOKS OF THE BUSHING AND SIDE A WAS WITHIN SPECIFICATION WHILE SIDE B WAS FOUND TO BE OUT OF SPECIFICATION, CONFIRMING THE REPORTED DEPLOYMENT FAILURE. A DIMENSIONAL ANALYSIS WAS PERFORMED ON THE YOKE AND IT WAS CONFIRMED TO BE WITHIN SPECIFICATION. NO OTHER ISSUES WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. THIS FAILURE IS LIKELY DUE TO PROBLEMS TRACED TO MANUFACTURING PROCESS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING DEFICIENCY. AN INVESTIGATION IS IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE GASTROINTESTINAL TRACT (GI) DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE, BUT FAILED TO RELEASE FROM THE CATHETER TO DEPLOY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED IN THE GASTROINTESTINAL TRACT (GI) DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE, BUT FAILED TO RELEASE FROM THE CATHETER TO DEPLOY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745194 RESOLUTION 360 CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION M00521232 0025239148 08714729875642

    Patients

    Seq Age Sex Outcome Treatment
    1