BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING

    MDR report key: 21119467 · Received January 9, 2025

    Report

    Report Number
    2124215-2024-83504
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729859437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K141150, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON RUPTURED OCCURRED. A 5.0MMX150MMX150CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367826 STERLING CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031501610 0030000382 08714729859437

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown