BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 ULTRA CLIP

    MDR report key: 22824588 · Received August 17, 2025

    Report

    Report Number
    3005099803-2025-04044
    Event Type
    Malfunction
    Date Received
    August 17, 2025
    Date of Event
    July 24, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729997269
    PMA / PMN Number
    K222503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF THE CLIP BEING DEPLOYED IN THE SCOPE. BLOCK H2 (ADDITIONAL INFORMATION): BLOCK E1 INITIAL REPORTER EMAIL HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 22, 2025.

    Additional Manufacturer Narrative · 0

    H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF THE CLIP BEING DEPLOYED IN THE SCOPE.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE RESOLUTION 360 ULTRA CLIPS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION 360 CLIPS DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE FOR POLYPS PERFORMED ON (B)(6) 2025. DURING INSERTION, ONE CLIP SPONTANEOUSLY DEPLOYED INSIDE THE ENDOSCOPE. NO DEPLOYMENT STEPS WERE TAKEN, AND THE CLIP DETACHED FROM THE CATHETER WITHOUT ANY STAFF INTERFERENCE. THE SAME PROBLEM OCCURRED WITH THE OTHER TWO RESOLUTION 360 ULTRA CLIP DEVICES. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 ULTRA CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE RESOLUTION 360 ULTRA CLIPS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION 360 CLIPS DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE FOR POLYPS PERFORMED ON (B)(6) 2025. DURING INSERTION, ONE CLIP SPONTANEOUSLY DEPLOYED INSIDE THE ENDOSCOPE. NO DEPLOYMENT STEPS WERE TAKEN, AND THE CLIP DETACHED FROM THE CATHETER WITHOUT ANY STAFF INTERFERENCE. THE SAME PROBLEM OCCURRED WITH THE OTHER TWO RESOLUTION 360 ULTRA CLIP DEVICES. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 ULTRA CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196045 RESOLUTION 360 ULTRA CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION M00521402 0036537642 08714729997269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown