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	02/06/2020
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 right femoral artery utilizing a contralateral approach.The 95% stenosed target lesion was located in the severely calcified left common femoral artery.A 6f non-bsc introducer sheath was inserted and a non-bsc guidewire crossed the lesion but severe calcification was observed and so pre-dilation was performed with a 6mmx2cm pcb balloon catheter at 6 atmospheres.And then, a 8.0mmx20mmx135cm sterling balloon catheter was advanced for dilatation.However, during first inflation at 4 atmospheres for 5 seconds, the balloon ruptured.Subsequently, a 8.0 x 20, 75cm mustang balloon catheter was advanced but it also ruptured at 6 atmospheres for 5 seconds.A non-bsc balloon catheter was used to complete the procedure.No patient complications were 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: 9752300
• Report Number: 2134265-2020-02034
• Device Sequence Number: 19384424
• 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
• Report Date (Section B): 02/25/2020

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: 10/31/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024697639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1