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

Model Number	24674
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation failure occurred.A 12.0 x 60, 75cm mustang balloon catheter was selected for use.However, during the procedure, the balloon would not deflate.The physician tried to switch to a 10ml syringe to deflate but it was unsuccessful.The balloon was inflated again and then was able to be deflated.The device was removed and the procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that deflation failure occurred.A 12.0 x 60, 75cm mustang balloon catheter was selected for use.However, during the procedure, the balloon would not deflate.The physician tried to switch to a 10ml syringe to deflate but it was unsuccessful.The balloon was inflated again and then was able to be deflated.The device was removed and the procedure was completed.There were no patient complications reported.It was further reported that the target lesion was located in the non-tortuous and non-calcified superior vena cava.The balloon was inflated to rated burst pressure several attempts before it was able to be deflated.

• 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: 10638034
• Report Number: 2134265-2020-13389
• Device Sequence Number: 19622780
• Product Code: FGE
• UDI-Device Identifier: 08714729794738
• UDI-Public: 08714729794738
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 05/13/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025508700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1