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

Model Number	24673
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Date of event: used (b)(6) 2019 as no event date was provided.Device evaluated by mfr.: a visual and microscopic examination was performed on the returned mustang device.A visual examination of the returned device confirmed that there was a longitudinal tear observed in the balloon material.The longitudinal tear in the balloon stretches for 100mm from the proximal edge of proximal markerband to the middle section of the balloon material.During analysis the investigator did not attempt to advance the device through a 5fr boston scientific sheath due to the condition of the balloon material.A visual and microscopic examination found no damage or any issues with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 12sep2019.It was reported that insertion difficulty was encountered.A 6.0 x 200, 75cm mustang balloon catheter was selected for use, but they encountered difficulty in going through the non-bsc 5fr sheath.There were no patient complications reported.However, returned device analysis revealed a longitudinal tear in 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: 9141270
• Report Number: 2134265-2019-11841
• Device Sequence Number: 3046194
• Product Code: LIT
• UDI-Device Identifier: 08714729794509
• UDI-Public: 08714729794509
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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: 09/05/2021
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0022616326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1