BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION 360 CLIP

    MDR report key: 20776235 · Received November 25, 2024

    Report

    Report Number
    3005099803-2024-05949
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729875628
    PMA / PMN Number
    K151802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF CLIP PREMATURE DEPLOYMENT WITH ANATOMICAL LOCATION OF ESOPHAGUS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP PREMATURELY DEPLOYED OFF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829379 RESOLUTION 360 CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL BOSTON SCIENTIFIC CORPORATION M00521230 0031411333 08714729875628

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male