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

Model Number	H74939171050610
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that froze on wire occurred.The target lesion was located in the coronary artery.A 5.0 x 60, 135cm mustang balloon catheter was used for dilation.Prior to the procedure, an attempt to insert the balloon catheter into the patient was unsuccessful and the balloon and guidewire became stuck together, resulting in both being withdrawn simultaneously.This same issue occurred with a second balloon catheter.The procedure was ultimately completed successfully using another device of the same type.There was no patient complication as a result of this event.
Additional Manufacturer Narrative
The device was returned for analysis.The recommended guidewire size for this device is 0.035 inches; however, the guidewire used by the customer was not returned for evaluation.The investigator successfully loaded the device onto a boston scientific 0.035-inch guidewire without any issues.The minimum recommended introducer or guide sheath size for this device is 5 french (5fr).The sheath utilized by the customer was also not returned for analysis.During the evaluation, the investigator successfully advanced the device through a boston scientific 5fr sheath and retrieved it without difficulty.Upon visual inspection, the balloon was observed to be tightly folded, which is indicative of the balloon not having been subjected to positive inflation pressure.No abnormalities or defects were noted in the balloon material.A combined visual and tactile examination of the device shaft revealed no kinks or structural damage.Additionally, no damage was identified upon visual inspection of the device tip.
Event or Problem Description
It was reported that froze on wire occurred.The target lesion was located in the coronary artery.A 5.0 x 60, 135cm mustang balloon catheter was used for dilation.Prior to the procedure, an attempt to insert the balloon catheter into the patient was unsuccessful and the balloon and guidewire became stuck together, resulting in both being withdrawn simultaneously.This same issue occurred with a second balloon catheter.The procedure was ultimately completed successfully using another device of the same type.There was no patient complication 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: 21830426
• Report Number: 2124215-2025-22540
• Device Sequence Number: 14525119
• Product Code: LIT
• UDI-Device Identifier: 08714729793878
• UDI-Public: (01)08714729793878(17)251019(10)30381489
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141597
• 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): 05/16/2025

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 Expiration Date: 10/19/2025
• Device Model Number: H74939171050610
• Device Catalogue Number: H74939171050610
• Device Lot Number: 0030381489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG