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

Model Number	24673
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
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 non-tortuous and severely calcified superficial femoral artery.A 5.0 x 200, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the non-tortuous and severely calcified superficial femoral artery.A 5.0 x 200, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
The mustang balloon was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 2mm proximal of the proximal markerband and extending approximately 25mm distally across the balloon material.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and microscopic examination found that both markerbands were undamaged and present on the shaft of the device.No other issues were identified during the product analysis.

• 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: 10706288
• Report Number: 2134265-2020-14483
• Device Sequence Number: 3345598
• Product Code: LIT
• UDI-Device Identifier: 08714729793373
• UDI-Public: 08714729793373
• 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): 12/03/2020

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: 06/18/2023
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0025616598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: PARENT; INTRODUCER SHEATH: PARENT; INTRODUCER SHEATH: PARENT