MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture occurred.A 10.0 x 40, 135cm mustang balloon catheter was used to dilate multiple areas within the anatomy in a venous angioplasty procedure.After an unknown manufacturer's nitinol stent was implanted, the same 10.0 x 40, 135cm mustang balloon catheter was advanced for post dilation.However, on the third inflation, the balloon burst.The 10.0 x 40, 135cm mustang balloon catheter could not be completely removed from the patient when deflated.The physician performed peripheral and pulmonary aortography but failed to locate the device fragment.The procedure was completed without further post dilatation being performed.There were no patient complications nor injuries reported.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13011882
• Report Number: 2134265-2021-15467
• Device Sequence Number: 1726842
• Product Code: FGE
• UDI-Device Identifier: 08714729793823
• UDI-Public: 08714729793823
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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 Expiration Date: 01/02/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024985175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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: Other; Required Intervention
• Patient Sex: Male