BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER

    MDR report key: 21324861 · Received February 6, 2025

    Report

    Report Number
    2124215-2025-06442
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729804697
    PMA / PMN Number
    K112697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: PATIENT IS 18 YEARS OR OLDER. D2B - PRO CODE (PRODUCT CODE): LIT. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K112701, K141521.

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: PATIENT IS 18 YEARS OR OLDER. D2B - PRO CODE (PRODUCT CODE): LIT. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K112701, K141521. DEVICE EVALUATED BY MFR: THE CHARGER WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. THE RATED BURST PRESSURE FOR THIS DEVICE IS 18 ATMOSPHERES. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 45MM DISTAL FROM THE PROXIMAL MARKERBAND. A VISUAL AND MICROSCOPIC EXAMINATION OF THE MARKERBANDS IDENTIFIED NO ISSUES. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO KINKS OR DAMAGE TO THE SHAFT. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO DAMAGE TO THE TIP OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED BRACHIAL ARTERY. AN 8.0 X80, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED BRACHIAL ARTERY. AN 8.0 X80, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908941 CHARGER STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939206080810 0033063835 08714729804697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown