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

Model Number	H74939171050440
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A 5.0 x 40, 40cm mustang balloon catheter was selected for transarterial vascular access interventional therapy (vaivt).Upon unpacking and taking out the device, the tip appeared to be detached.The procedure was completed with another device of a different lot.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the device was returned for analysis.Upon visual inspection, it was observed that the balloon had not been inflated and remained tightly folded.Examination of the marker bands revealed no abnormalities.A thorough visual and tactile assessment of the shaft detected no kinks or damage.However, a similar examination identified damage to the tip.
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A 5.0 x 40, 40cm mustang balloon catheter was selected for transarterial vascular access interventional therapy (vaivt).Upon unpacking and taking out the device, the tip appeared to be detached.The procedure was completed with another device of a different lot.There were no patient complications as a result of this event.

• 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: 21598993
• Report Number: 2124215-2025-13885
• Device Sequence Number: 9034759
• Product Code: LIT
• UDI-Device Identifier: 08714729793731
• UDI-Public: (01)08714729793731(17)271122(10)35342281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: H74939171050440
• Device Catalogue Number: H74939171050440
• Device Lot Number: 0035342281
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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 Sex: Unknown