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	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: a mustang 12.0 x 20, 75cm 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 16mm proximal from the proximal markerband.No other issues were noted.A visual and microscopic examination of the balloon material identified no other issues.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.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 10-aug-2020.It was reported that hub leak occurred.A 12.0 x 20, 75cm mustang balloon catheter was advanced for dilatataion.However, pressure could not be applied and leakage was observed from the hub part.The procedure was completed with a different device.There were no patient complications reported.However, returned 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: 10473353
• Report Number: 2134265-2020-11172
• Device Sequence Number: 2828563
• Product Code: FGE
• UDI-Device Identifier: 08714729793922
• UDI-Public: 08714729793922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/31/2020

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: 05/12/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023780900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1