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	11/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the non tortuous and non calcified iliac artery.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation within specified pressure, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patient status wa stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the non tortuous and non calcified iliac artery.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation within specified pressure, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patient status wa stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual and microscopic examination identified a balloon longitudinal tear beginning approximately 10mm distal of the distal markerband and extending approximately 55mm proximally across the balloon material.The balloon tear was then noted to extend circumferentially in a partial tear across the balloon material from the proximal end of the longitudinal tear.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no issues with the tip of the device that could have contributed to the complaint incident.No kinks or damage was noted to 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: 8135404
• Report Number: 2134265-2018-63571
• Device Sequence Number: 11276755
• Product Code: FGE
• UDI-Device Identifier: 08714729793823
• UDI-Public: 08714729793823
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/22/2019

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: 02/03/2020
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0020246969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1