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	08/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon tear occurred.The target location was located in a right lower extremity vein.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.However, there was no resistance felt on the inflation device when they went to deploy the balloon.The physician then pulled negative, and the inflation device filled with blood.The device was removed from the patient's body.Upon inflation on the table, the balloon leaked contrast and could not even hold up to 1 atmosphere of pressure.A tear was noted on the balloon and the procedure was completed with another of the same device.No patient complications 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: 9079019
• Report Number: 2134265-2019-10868
• Device Sequence Number: 11381929
• Product Code: FGE
• UDI-Device Identifier: 08714729795018
• UDI-Public: 08714729795018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 10/04/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022755660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR