BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 CLIP

    MDR report key: 23254435 · Received October 9, 2025

    Report

    Report Number
    3005099803-2025-05264
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    PMA / PMN Number
    K151802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT AT AN UNKNOWN ANATOMY LOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CLIP DEPLOYED PRIOR TO SQUEEZING THE HANDLE AND FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481103 RESOLUTION 360 CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION M00521230 0035966973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown