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

Model Number	H74939171080410
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon rupture and was difficult to withdraw.The patient underwent subclavian artery stenosis procedure using an 8.0 x 40, 135cm mustang balloon catheter.After unpacking, the balloon was soaked in saline, inserted at the lesion site, and inflated at standard pressure.During removal, the balloon was difficult to withdraw.Subsequently, the balloon burst and was eventually removed from the patient.Due to brain protection device, it did not cause any adverse effects.The procedure was completed with another of the same device, and the patient condition following procedure was stable.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.The mustang was returned for analysis and investigation was completed on (b)(6) 2025.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test identified a balloon pinhole located approximately 13mm distal of the proximal markerband.The rated burst pressure for this device as per specification (b)(4) is 20 atmospheres.A sheath insertion/withdrawal test could not be carried out due to a pinhole in the balloon of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Markerbands were undamaged in the correct position on the device.
Event or Problem Description
It was reported that the balloon rupture and was difficult to withdraw.The patient underwent subclavian artery stenosis procedure using an 8.0 x 40, 135cm mustang balloon catheter.After unpacking, the balloon was soaked in saline, inserted at the lesion site, and inflated at standard pressure.During removal, the balloon was difficult to withdraw.Subsequently, the balloon burst and was eventually removed from the patient.Due to brain protection device, it did not cause any adverse effects.The procedure was completed with another of the same device, and the patient condition following procedure was stable.

• 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: 21542539
• Report Number: 2124215-2025-14101
• Device Sequence Number: 12673242
• Product Code: FGE
• UDI-Device Identifier: 08714729793663
• UDI-Public: 08714729793663
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 08/15/2026
• Device Model Number: H74939171080410
• Device Catalogue Number: H74939171080410
• Device Lot Number: 0032223245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 79 KG