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	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a vessel.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during third inflation at 8 atmospheres, the balloon ruptured based on the fluoroscopy.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 12 x 4,135cm, was returned for analysis.A visual examination identified that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied.The balloon was inflated to its rate of burst pressure of 14 atmospheres.No issues were noted on deflation.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual and microscopic examination of the marker bands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft.A visual and tactile examination identified no issues with tip of this device.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a vessel.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during third inflation at 8 atmospheres, the balloon ruptured based on the fluoroscopy.The device was removed and the procedure was completed with a different device.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
• MDR Report Key: 10771411
• Report Number: 2134265-2020-15131
• Device Sequence Number: 19868822
• Product Code: FGE
• UDI-Device Identifier: 08714729793953
• UDI-Public: 08714729793953
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/28/2020

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: 01/22/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025092389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: RADIFOCUS; GUIDE WIRE: RADIFOCUS; GUIDE WIRE: RADIFOCUS