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	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The (b)(4) stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.An 8.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, on initial inflation at 24 atmospheres for 5 seconds, the balloon ruptured.The device was removed without problem and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(e1) initial reporter city: (b)(6).Device evaluated by mfr.: mustang 8.0 x 20, 75cm 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, measuring 42mm in length, starting at 10 mm proximal to the proximal marker band and extending to 2 mm distal past the distal marker band.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 found no issues with the device shaft.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.An 8.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, on initial inflation at 24 atmospheres for 5 seconds, the balloon ruptured.The device was removed without problem and the procedure was completed with another of the same device.There were no patient complications 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: 10069317
• Report Number: 2134265-2020-06686
• Device Sequence Number: 3881253
• Product Code: FGE
• UDI-Device Identifier: 08714729793519
• UDI-Public: 08714729793519
• 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): 06/30/2020

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: 10/15/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024609076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1