BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 23273224 · Received October 10, 2025

    Report

    Report Number
    2124215-2025-72336
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K141150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER CITY: (B)(6). E1 - INITIAL REPORTER PHONE: 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 MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0MMX100MMX150CM STERLING CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 6 ATMOSPHERES FOR 5 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
    2264643 STERLING? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031501110 0032679700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BALLOON CATHETER USED: 6F SHIDENHP 6-150| GUIDEWIRE USED: JUPITER FC 300CM| INTRODUCER SHEATH USED: 6F CROSSROAD MG