BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 CLIP

    MDR report key: 19537309 · Received June 14, 2024

    Report

    Report Number
    3005099803-2024-02813
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729875635
    PMA / PMN Number
    K222503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED TO MAY 1, 2024 BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK E1: INITIAL REPORTER ADDRESS 1: CNR PRINCES HWY & VILLAGE AVENUE. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP DID NOT DEPLOY.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO THE ONE OF TWO RESOLUTION 360 CLIPS THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP DEVICE WAS USED FOR POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED AN UNKNOWN DATE. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION 360 CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183034 RESOLUTION 360 CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION M00521231 0032199317 08714729875635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown