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

Model Number	24674
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The stenosed target lesion was located in the common bile duct artery.A 12.0 x 20, 135cm mustang balloon catheter was advanced for dilation.When the physician injected contrast agent in pump, the balloon could not be fully inflated.The device was withdrawn and flushed outside the patient's body; however, a leak was found and a visible pinhole was noted on the balloon material.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• 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: 10695560
• Report Number: 2134265-2020-14322
• Device Sequence Number: 11689600
• Product Code: FGE
• UDI-Device Identifier: 08714729794356
• UDI-Public: 08714729794356
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/16/2020

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: 10/05/2020
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0021224724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 75