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	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
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 right common iliac artery.A 6f non-bsc introducer sheath was inserted.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 5.00x20mm sterling balloon catheter at 14 atmospheres.After the 8mmx27mm express ld stent was placed, post dilatation was performed with a 7.0mmx20mmx135cm sterling balloon catheter.However, during the first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed from the patient's body and it was replaced with a 8.0 x 20, 135cm mustang balloon catheter.However, the balloon also ruptured in the first inflation after being inflated at 10 atmospheres for 10 seconds.The device was completely removed and the procedure was completed with another 8mmx4cm mustang balloon catheter.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: 10155252
• Report Number: 2134265-2020-07919
• Device Sequence Number: 13976874
• Product Code: FGE
• UDI-Device Identifier: 08714729793847
• UDI-Public: 08714729793847
• 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): 06/15/2020

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: 01/30/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025138700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1