BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 24579163 · Received March 12, 2026

    Report

    Report Number
    2124215-2026-13834
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793793
    PMA / PMN Number
    K141521
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597. E1: INITIAL REPORTER PHONE: (B)(6). INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE MUSTANG DEVICE CONFIRMED THAT THE EVENT OF BALLOON FAILURE TO DEFLATE IS A KNOWN EVENTS DEFINED IN THE PRODUCTS RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC CONCLUDES THE MOST PROBABLE ROOT CAUSE AS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT BECAUSE THE INABILITY TO DEFLATE AS A FAILURE MODE CAN TYPICALLY ONLY RESULT FROM THREE MAIN CAUSES: SEVERE KINKING OF THE CATHETER, INGRESS OF BODILY FLUIDS (VIA OTHER DEVICE DAMAGE) THAT BLOCKS THE LUMEN, OR OCCLUSION BY OTHER MATERIAL. THE BALLOON WAS ABLE TO BE INFLATED INITIALLY AS PART OF THE PROCEDURE, SO ANY OCCLUSION APPEARS TO HAVE BEEN INTRODUCED PRIOR TO USE. SINCE THE BALLOON WAS NOT REPORTED TO HAVE OTHER DAMAGE (KINKS OR OTHER DAMAGE THAT WOULD ALLOW BODILY FLUID TO BLOCK THE LUMEN), THE MOST PROBABLE REASON FOR THE EVENT WAS OCCLUSION BY SOME OUTSIDE MATERIAL. THIS IS FURTHER CONFIRMED BY THE REPORTED INFORMATION SUGGESTING THAT THERE WAS A POTENTIAL INCLUSION OF MEDICAL GLUE INTO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED REQUIRING ADDITIONAL INTERVENTION. ON (B)(6) 2026, THE PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE DURING WHICH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATION CATHETER WAS USED IN THE STANDARD MANNER. THE PATIENT ANATOMY WAS NOT CHALLENGING, AND THERE WAS NO NARROWING LESION. AN AMPLATZ ULTRA-HARD GUIDEWIRE WAS ADVANCED TO THE DISTAL SPLENIC VEIN, AND A 6.0 X 80 MM, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED TO DILATE THE PUNCTURE TRACT AND EXPAND THE LIVER PARENCHYMA. FOLLOWING DILATION, THE BALLOON FAILED TO DEFLATE, AND THE BALLOON PRESSURE COULD NOT BE REDUCED, RESULTING IN A DELAY IN THE PROCEDURE. THE SURGEON SUSPECTED THAT THE ASSISTANT MAY HAVE INADVERTENTLY MIXED MEDICAL GLUE INTO THE CONTRAST AGENT, CAUSING OCCLUSION OF THE BALLOON LUMEN AND PREVENTING NORMAL BALLOON DEFLATION AND RETRACTION. PROLONGED INABILITY TO DEFLATE THE BALLOON POSED A POTENTIAL RISK TO THE PATIENT'S BLOOD VESSELS. TO MITIGATE THIS RISK, THE PHYSICIAN PROMPTLY PUNCTURED THE BALLOON, ALLOWING SUCCESSFUL DEFLATION AND RETRIEVAL OF THE DEVICE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642462 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171060810 0036682565 08714729793793

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention GUIDEWIRE: AMPLATZ