BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 22666126 · Received July 30, 2025

    Report

    Report Number
    2124215-2025-52009
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729859437
    PMA / PMN Number
    K141150
    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 A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0MMX150MMX150CM (4F) STERLING MR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR ONE MINUTE. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549759 STERLING? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031501610 0032956489 08714729859437

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown