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	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.It was further reported that the balloon ruptured during the initial inflation at below rated burst pressure and the device was completely removed from the patient's body.
Additional Manufacturer Narrative
B5 describe event or problem: updated event description.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10579859
• Report Number: 2134265-2020-13259
• Device Sequence Number: 16838884
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: 08714729793861
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 02/26/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025277148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR