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	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via femoral artery utilizing a contralateral approach.The stenosed target lesion was located in the right popliteal artery.After a guidewire crossed the lesion, a 4.0 x 100, 135cm mustang balloon catheter was advanced for dilation.However, during first inflation at 15 atmospheres, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via femoral artery utilizing a contralateral approach.The stenosed target lesion was located in the right popliteal artery.After a guidewire crossed the lesion, a 4.0 x 100, 135cm mustang balloon catheter was advanced for dilation.However, during first inflation at 15 atmospheres, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion was 80% stenosed, moderately tortuous, and moderately calcified.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).

• 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: 11023972
• Report Number: 2134265-2020-18030
• Device Sequence Number: 11822755
• Product Code: FGE
• UDI-Device Identifier: 08714729793717
• UDI-Public: 08714729793717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103751
• 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): 12/23/2020

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: 12/18/2020
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0021532800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1