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

Model Number	H74939171060870
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.D2b pro code (product code): fge, lit.
Event or Problem Description
It was reported that balloon ruptured, and the tip was detached, requiring intervention.A 6.0 x 80, 75cm mustang balloon catheter was advanced for treating a dialysis graft.During the procedure, the balloon was inflated up to rated burst pressure, but it ruptured immediately.Upon removal, the distal end of the catheter must have been caught on a plaque and migrated.A snare was then used to remove the foreign body.The procedure was completed using an alternate device.No complications were reported.
Additional Manufacturer Narrative
B3 date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.D2b pro code (product code): fge, lit.Device evaluation by manufacturer: the mustang device 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 full balloon circumferential tear was identified located approximately 8mm proximal from the proximal balloon markerband.The remainder of the balloon was not returned with the device.A visual examination observed that the distal section of the device including the tip was not returned for analysis.A visual and tactile examination found the shaft to be detached on 3 locations along the length of the shaft.The inner shaft that was detached was noted to be accordioned and stretched.The markerbands were detached from the inner shaft and was not returned with the device.
Event or Problem Description
It was reported that balloon ruptured, and the tip was detached, requiring intervention.A 6.0 x 80, 75cm mustang balloon catheter was advanced for treating a dialysis graft.During the procedure, the balloon was inflated up to rated burst pressure, but it ruptured immediately.Upon removal, the distal end of the catheter must have been caught on a plaque and migrated.A snare was then used to remove the foreign body.The procedure was completed using an alternate device.No complications were reported.

• 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: 21200792
• Report Number: 2124215-2024-83753
• Device Sequence Number: 18032238
• Product Code: FGE
• UDI-Device Identifier: 08714729793854
• UDI-Public: 08714729793854
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171060870
• Device Catalogue Number: H74939171060870
• Device Lot Number: 0033131254
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown