BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 23187433 · Received September 30, 2025

    Report

    Report Number
    2124215-2025-68857
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    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 BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A STERLING 6.0MMX150MMX150CM WAS ADVANCED FOR DILATATION. DURING THE SECOND INFLATION AT 14 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014304 STERLING? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031601610 0035036391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown