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

Model Number	24674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang was returned for analysis.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and a pinhole leak was identified 8mm proximal from the proximal markerband.No other issues were noted.The rated burst pressure for this device was 24 atmospheres as per the print on the hub.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 06apr2020.It was reported that balloon leak occurred.The target lesion was located in the arteriovenous fistula in the arm.A 6.0 x 20, 40cm mustang balloon catheter was advanced for dilatation.However, the device was unable to inflate.Balloon was took out of the patient's body and inspected and a leak was noted in the balloon.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed balloon pinhole.

• 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: 10010689
• Report Number: 2134265-2020-04968
• Device Sequence Number: 2897702
• Product Code: FGE
• UDI-Device Identifier: 08714729793908
• UDI-Public: 08714729793908
• 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
• Report Date (Section B): 04/29/2020

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: 07/24/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024164827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1