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

Model Number	H74939171040670
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b- pro code (product code): lit.E1 - initial reporter facility name: (b)(6).G4 - premarket / 510(k) #: k110122.
Event or Problem Description
It was reported that the shaft break occurred.The stenosed target lesion was located in an arteriovenous fistula.A 4.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the middle of the balloon catheter shaft broke inside the patient.The procedure was completed with a different device.No patient complications were reported, and the patient status 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: 20925184
• Report Number: 2124215-2024-78982
• Device Sequence Number: 5068548
• Product Code: FGE
• UDI-Device Identifier: 08714729794349
• UDI-Public: 08714729794349
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103751
• 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
• Report Date (Section B): 12/13/2024

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: 09/27/2025
• Device Model Number: H74939171040670
• Device Catalogue Number: H74939171040670
• Device Lot Number: 0030233872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 09/28/2022
• 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: 60 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG