BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING

    MDR report key: 21585127 · Received March 12, 2025

    Report

    Report Number
    2124215-2025-15256
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 12, 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 MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX100MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR LESS THAN 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547232 STERLING CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031601110 0034615479 08714729859581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: GLADIUS MG| INFLATION DEVICE: GM30| INTRODUCER SHEATH: DESTINATION 6FR