BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 23678054 · Received December 1, 2025

    Report

    Report Number
    2124215-2025-87810
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 20, 2025
    Report Date
    February 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793762
    PMA / PMN Number
    K141521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597. THE MUSTANG DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON HAD BEEN SUBJECTED TO POSITIVE PRESSURE. A PINHOLE IN THE BALLOON MATERIAL WAS IDENTIFIED CONFIRMING THE EVENT. NO DAMAGE OR ISSUES WERE FOUND WITH THE TIP OR MARKERBANDS OF THE DEVICE. SHAFT KINKS WERE ALSO NOTED. 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

    B5 - DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON BURST. NO ADDITIONAL INFORMATION WAS REPORTED. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. THE PATIENT'S ANATOMY WAS CONSIDERED CHALLENGING. IT WAS ALSO REPORTED THAT THE BALLOON REMAINED RUPTURED FOR APPROXIMATELY 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON BURST. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON BURST. NO ADDITIONAL INFORMATION WAS REPORTED. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. THE PATIENTS ANATOMY WAS CONSIDERED CHALLENGING. IT WAS ALSO REPORTED THAT THE BALLOON REMAINED RUPTURED FOR APPROXIMATELY 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727755 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171060670 0037196180 08714729793762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown