BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING® SL

    MDR report key: 24505737 · Received March 4, 2026

    Report

    Report Number
    24505737
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING AN ATTEMPTED ENDOVASCULAR BALLOON ANGIOPLASTY OF THE LEFT ANTERIOR TIBIAL ARTERY, THE BALLOON WAS BROKEN IN THE ARTERY. A SURGICAL CUTDOWN WAS SUBSEQUENTLY PERFORMED TO RETRIEVE THE BALLOON. THE PROCEDURE WAS PERFORMED UNDER CONTINUOUS FLUOROSCOPY, AND THE ATTENDING SURGEON CONFIRMED COMPLETE REMOVAL OF THE BALLOON FROM THE ARTERY. THE FACULTY SURGEON PUT IN A NOTE DETAILING COMPLETE REMOVAL; THE BALLOON WAS GIVEN TO CHARGE (BOSTON SCIENTIFIC STERLING 0.018" 3.0 X 150X 150 BALLOON; REF# H74939148301510/ EXP: 11-12-2027/ LOT: 37941758)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52090 STERLING® SL CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939148301510 37941758

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other