BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK

    MDR report key: 23442542 · Received October 31, 2025

    Report

    Report Number
    2124215-2025-78666
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729370086
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: UNIT OF MEASURE - AGE: CORRECTED DEVICE EVALUATED BY MFR.: FG MAVERICK 2 MR, 2.50MM X 15MM WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE NOTED MULTIPLE KINKS ALONG ITS LENGTH. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT POLYMER EXTRUSION IDENTIFIED NO KINKS OR DAMAGES. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO TEARS OR PINHOLES IN THE BALLOON. A MICROSCOPIC EXAMINATION OF THE TIP SHOWED NO SIGNS OF TIP DAMAGE. USING AN ENCORE INFLATION UNIT, THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES (ATM). THE BALLOON INFLATED FULLY AND MAINTAINED PRESSURE FOR 15 SECONDS, WITH NO LEAKS NOTED. A VACUUM WAS APPLIED, AND THE BALLOON DEFLATED FULLY WITH NO RESISTANCE. THE BALLOON WAS INFLATED TO ITS RBP ON THREE MORE OCCASIONS WITH NO LEAKS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON BURST DUE TO SEVERAL CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON BURST DUE TO SEVERAL CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457849 MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493892815250 0036621791 08714729370086

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female