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

Model Number	24674
Medical Device Problem Code	Failure to Advance (2524)
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
Device evaluated by mfr: visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 10mm distal to the distal edge of the distal markerband and extending approximately 69mm 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.Visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.Visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A microscopic examination identified no damage or issues with the tip which could potentially have 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 15-feb-2019.It was reported that crossing difficulties were encountered.The target lesion was located in the iliac artery.A 12.0 x 80, 75cm mustang balloon catheter was advanced for dilatation; however, the tip of the balloon catheter became stuck at the bifurcation of the iliac artery and the device failed to cross the lesion.The procedure was completed with this device.No patient complications were reported.However, returned device analysis revealed balloon longitudinal tear.

• 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: 8416003
• Report Number: 2134265-2019-02412
• Device Sequence Number: 1789893
• 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: 09/27/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022721071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• 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: 69 YR