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	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt in the brachiocephalic artery.A 7.0 x 120, 75cm mustang balloon catheter was advanced for insufflation.However, after inflation, it was noted that the balloon ruptured.The lesion was insufflated enough to complete the procedure with this device.No patient complications nor serious injuries were noted.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt in the brachiocephalic artery.A 7.0 x 120, 75cm mustang balloon catheter was advanced for insufflation.However, after inflation, it was noted that the balloon ruptured.The lesion was insufflated enough to complete the procedure with this device.No patient complications nor serious injuries were noted.The device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning approximately 8mm proximal of the proximal markerband and extending approximately 25mm distally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no issues with the tip of the device which could potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/21/2018 11:30 am ct.The report number is being corrected from: 2134265-2018-64581 to: 2134265-2018-63547.

• 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: 8142464
• Report Number: 2134265-2018-63547
• Device Sequence Number: 950455
• Product Code: FGE
• UDI-Device Identifier: 08714729794424
• UDI-Public: 08714729794424
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 07/31/2021
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0022456092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1