BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 23397497 · Received October 27, 2025

    Report

    Report Number
    2124215-2025-76806
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729859581
    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 BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 6 ATMOSPHERES FOR 1 SECOND. 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
    2428273 STERLING? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031601110 0031036062 08714729859581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BALLOON CATHETER - SHIDEN HP 6-100| GUIDEWIRE - ASAHI INTECC CROSSLEAD TRACKER| STENT - ELUVIA 6-150,7-150