MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939171100810
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.E1 - initial reporter phone: (b)(6).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.
Event or Problem Description
It was reported that a balloon rupture occurred.The patient, diagnosed with deep vein thrombosis in the right lower extremity and pulmonary embolism, underwent placement of an inferior vena cava filter, aspiration of the right lower-extremity thrombus, and catheter-directed thrombolysis.The target lesion was located in the right lower extremity.A 10.0 x 80, 135cm mustang balloon catheter was advanced for vessel dilatation.After insertion of the pta balloon catheter, contrast was injected using a disposable inflation device.The balloon did not achieve full inflation, and the patient reported pain and numbness in the affected limb.The device was emptied and removed from the patient.Upon inspection, the balloon was found to be damaged.A small rupture measuring less than 1 mm was observed on the balloon surface, with contrast noted to be leaking in a thin stream.The procedure was discontinued to prevent complications.Thrombolysis was subsequently continued using a perfusion system.No further adverse events were reported, and the patient was safely returned to the ward.
Event or Problem Description
It was reported that a balloon rupture occurred.The patient, diagnosed with deep vein thrombosis in the right lower extremity and pulmonary embolism, underwent placement of an inferior vena cava filter, aspiration of the right lower-extremity thrombus, and catheter-directed thrombolysis.The target lesion was located in the right lower extremity.A 10.0 x 80, 135cm mustang balloon catheter was advanced for vessel dilatation.After insertion of the pta balloon catheter, contrast was injected using a disposable inflation device.The balloon did not achieve full inflation, and the patient reported pain and numbness in the affected limb.The device was emptied and removed from the patient.Upon inspection, the balloon was found to be damaged.A small rupture measuring less than 1mm was observed on the balloon surface, with contrast noted to be leaking in a thin stream.The procedure was discontinued to prevent complications.Thrombolysis was subsequently continued using a perfusion system.No further adverse events were reported, and the patient was safely returned to the ward.It was further reported that the target lesion was 50% stenosed.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.(b)(6).G4: premarket / 510(k): k141521, k141597.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 balloon device confirmed that the event of balloon material rupture and balloon damaged/defective are 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 adverse event related to patient condition based on there being no reported device interaction/ damage or issue until the balloon was inflated in the thrombosed vessel.This would suggest that patient anatomy most probably contributed to the balloon rupture/damage.It is not possible to determine the cause of the pain and numbness.

• Brand Name: MUSTANG?
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24520550
• Report Number: 2124215-2026-10979
• Device Sequence Number: 20940086
• Product Code: FGE
• UDI-Device Identifier: 08714729795254
• UDI-Public: (01)08714729795254(17)280527(10)36619908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171100810
• Device Catalogue Number: H74939171100810
• Device Lot Number: 0036619908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male