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	10/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.A 8.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.However,during inflation, the pressure could not be increased.When the device was pulled out, leakage in the proximal end of the balloon was noted and there appeared to be a pinhole.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
(b5) describe event or problem updated.
Event or Problem Description
It was reported that balloon leak occurred.An 8.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.However,during inflation, the pressure could not be increased.When the device was pulled out, leakage in the proximal end of the balloon was noted and there appeared to be a pinhole.The procedure was completed with a different device.No patient complications were reported.It is further reported that there was no visible pinhole found before inflation and it was after the third inflation that the leakage was noted in proximal of the balloon.

• 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: 9345594
• Report Number: 2134265-2019-13963
• Device Sequence Number: 208539
• Product Code: FGE
• UDI-Device Identifier: 08714729793519
• UDI-Public: 08714729793519
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 12/05/2019

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: 04/30/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023722235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR