MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24672
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, during the third inflation at 20 atmospheres, the balloon ruptured.The device was completely removed without any issure and the procedure was completed with another of the same device.No patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang 6.0 x 150, 135cm, batch # 23974767 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 in the balloon material.The tear measured 40mm in length and extended from a position 3mm proximal from the proximal marker band and extending 37mm distally from the proximal markerband.A visual and microscopic examination of the marker bands identified no issues.A visual and tactile examination found issues with the device shaft.A shaft kink was noted 4mm distal from the proximal markerband.A visual and tactile examination identified no damage to the tip.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed, target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.A 6.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, during the third inflation at 20 atmospheres, the balloon ruptured.The device was completely removed without any issure noted and the procedure was completed with another of the same devce.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: 10280428
• Report Number: 2134265-2020-09410
• Device Sequence Number: 2624479
• Product Code: LIT
• UDI-Device Identifier: 08714729793458
• UDI-Public: 08714729793458
• 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): 08/04/2020

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: 06/17/2022
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0023974767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1