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	08/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient serious injury or adverse event were reported.
Additional Manufacturer Narrative
The returned balloon had a 75mm long longitudinal tear stretching from the distal end of the balloon to the mid-section of the balloon.An examination of the balloon material identified no other issues which could potentially have contributed to this complaint.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and microscopic examination of the tip was completed.No damage or any issues were noted with the tip that could have contributed to the complaint incident.A visual and microscopic examination of the markerbands was completed.There was no burrs or uneven edges observed on the markerbands.No damage or any issues were noted with the markerbands that could have contributed to the complaint incident.No other issues were identified during device analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient serious injury or adverse event 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: 8939706
• Report Number: 2134265-2019-10349
• Device Sequence Number: 19343153
• Product Code: FGE
• UDI-Device Identifier: 08714729793700
• UDI-Public: 08714729793700
• 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,Followup
• Report Date (Section B): 10/02/2019

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: 06/19/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023982970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1