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

Model Number	H74939171060870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: lit.G4 - premarket / 510(k): k141597.
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in the moderately tortuous and mild calcified radial arteriovenous fistula.A 6.0 x 80, 75cm mustang catheter was advanced for dilation.During the procedure, the balloon burst during second inflation at 24 atmospheres up to the rated burst pressure (rbp) for 30 seconds.The procedure was completed with another of same device.No complications were reported, and the patient condition was stable.
Additional Manufacturer Narrative
D2b: pro code: lit.G4 - premarket / 510(k): k141597.Device evaluated by mfr: the mustang was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 10mm in length and extended from a position 8mm proximal of the distal markerband to 1mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in the moderately tortuous and mild calcified radial arteriovenous fistula.A 6.0 x 80, 75cm mustang catheter was advanced for dilation.During the procedure, the balloon burst during second inflation at 24 atmospheres up to the rated burst pressure (rbp) for 30 seconds.The procedure was completed with another of same device.No complications were reported, and the patient condition 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: 20965085
• Report Number: 2124215-2024-80186
• Device Sequence Number: 12852345
• Product Code: FGE
• UDI-Device Identifier: 08714729793854
• UDI-Public: 08714729793854
• 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,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: H74939171060870
• Device Catalogue Number: H74939171060870
• Device Lot Number: 0034670601
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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 Age: 57 YR
• Patient Sex: Male