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

Model Number	H74939171100870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: fge, lit g4: pma/510(k) #: k141521, k141597.
Event or Problem Description
It was reported that the balloon was ruptured occurred.A 10.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured just prior to the intended pressure being achieved.The device was subsequently removed, and the procedure was successfully completed using another device of the same type.There were no patient complications reported.
Additional Manufacturer Narrative
D2b: fge, lit.G4: pma/510(k) #: k141521, k141597.The device was returned for analysis.Upon visual inspection, it was determined that the balloon was not folded, indicating that it had been subjected to positive pressure.The rated burst pressure for this device is 14 atmospheres, as specified in the mustang specifications.The returned device was connected to an encore inflation unit.During the application of positive pressure, di water was observed leaking from a pinhole in the balloon, located approximately 1 mm proximal to the distal marker band.A visual inspection of the marker bands revealed no issues.A combined visual and tactile examination of the shaft identified no kinks or damage.Additionally, a visual and tactile examination of the tip confirmed no damage.
Event or Problem Description
It was reported that the balloon was ruptured occurred.A 10.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured just prior to the intended pressure being achieved.The device was subsequently removed, and the procedure was successfully completed using another device of the same type.There were no patient complications reported.

• 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: 21589916
• Report Number: 2124215-2025-15418
• Device Sequence Number: 8350682
• Product Code: LIT
• UDI-Device Identifier: 08714729794332
• UDI-Public: (01)08714729794332(17)261203(10)32975205
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: H74939171100870
• Device Catalogue Number: H74939171100870
• Device Lot Number: 0032975205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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: 82 YR
• Patient Sex: Male