BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING

    MDR report key: 20815508 · Received December 1, 2024

    Report

    Report Number
    2124215-2024-75681
    Event Type
    Malfunction
    Date Received
    December 1, 2024
    Date of Event
    November 28, 2024
    Report Date
    December 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729859260
    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 - ADDITIONAL PREMARKET / 510(K): K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RENAL ARTERY. A 4.0MMX15MMX135CM (4F) STERLING WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445283 STERLING CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939031401510 0032009978 08714729859260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDE CATHETER: MACH1 8FR| GUIDEWIRE: MEISTER| INTRODUCER SHEATH: 8FR SHEATH