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

Model Number	24674
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear beginning approximately 5mm distal to the distal edge of the distal markerband and extending approximately 67mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the tip of the device.A visual and tactile examination identified no issues or damage along the length of the device.The recommended introducer/guide sheath size for this device is a 7fr sheath.The customer's sheath was not returned for analysis.During analysis the investigator was unable to advance the device through a 7fr boston scientific sheath due to the condition of the balloon material.No other issues were noted with the device that could potentially have contributed to the complaint incident.Date of event reported as both (b)(6) 2018 and (b)(6) 2018.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that advancing difficulties were encountered.The target lesion was located in an arteriovenous fistula.A 12.0 x 80, 75cm mustang balloon catheter was advanced for treatment and was removed after post-dilatation.The physician attempted to re-insert the device but failed to advance through the 7fr introducer sheath.The procedure was completed with this device.No patient complications were reported and the patient's status was good.However, returned device analysis revealed a longitudinal tear in the balloon material.

• 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: 8416789
• Report Number: 2134265-2019-02400
• Device Sequence Number: 1516192
• Product Code: FGE
• UDI-Device Identifier: 08714729794745
• UDI-Public: 08714729794745
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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: 09/11/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022645333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR