BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 21105124 · Received January 8, 2025

    Report

    Report Number
    3005099803-2024-06837
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 1, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PKL
    UDI-DI
    08714729504795
    PMA / PMN Number
    K142973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK G4 (PREMARKET / 510(K) #): K222503. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF CLIP UNABLE TO DEPLOY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. IT WAS REPORTED THAT THE CLIP UNABLE TO DEPLOY. THE DEVICE WAS CHANGED, BUT THERE WAS NO INFORMATION AS TO WHAT DEVICE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536085 RESOLUTION CLIP CLIP, HEMOSTATIC PKL BOSTON SCIENTIFIC CORPORATION M00522610 0031610993 08714729504795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown