BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 21937708 · Received April 30, 2025

    Report

    Report Number
    2124215-2025-27658
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 14, 2025
    Report Date
    July 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793342
    PMA / PMN Number
    K141521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K141521, K141597. THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A BALLOON LONGITUDINAL TEAR WAS IDENTIFIED BEGINNING AT THE PROXIMAL MARKERBAND AND EXTENDING APPROXIMATELY 43MM DISTALLY ACROSS THE BALLOON MATERIAL. THE RATED BURST PRESSURE FOR THIS DEVICE AS PER SPECIFICATION IS 20 ATMOSPHERES. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE TO THE SHAFT OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL EXAMINATION OBSERVED NO ISSUES WITH THE MARKERBANDS OF THE DEVICE. BOTH MARKERBANDS WERE UNDAMAGED IN THE CORRECT POSITION ON THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K141521, K141597.

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, LIT G4 - PREMARKET / 510(K): K141521, K141597.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS SHUNT. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED BEFORE IT REACHED NOMINAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS TOTALLY STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS SHUNT. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED BEFORE IT REACHED NOMINAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS SHUNT. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED BEFORE IT REACHED NOMINAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS TOTALLY STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED. THE DEVICE IS EXPECTED FOR ANALYSIS BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181373 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171070470 0034740038 08714729793342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown