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

Model Number	24674
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the superficial femoral artery.A 5.0 x 20, 135cm mustang balloon catheter was advanced for dilation.However, it was noted to be stuck in the wire.The devices were removed and the procedure was completed with another wire and balloon.No patient complications were reported and the patient status was fine.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the superficial femoral artery.A 5.0 x 20, 135cm mustang balloon catheter was advanced for dilation.However, it was noted to be stuck in the wire.The devices were removed and the procedure was completed with another wire and balloon.No patient complications were reported and the patient status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received with the guidewire trapped inside the wire lumen of the mustang device.It was not possible to remove.A visual and tactile examination of the device found that the catheter and the guidewire, inside the catheter, were kinked at 89.8cm distal to the strain relief.The shaft and guidewire were dissected just distal to the kink site.The distal section of the guidewire was removed from the distal section of the dissected catheter.When an attempt was made to withdraw the proximal section of the guidewire from the proximal section of the dissected device, a slight resistance was noted as the kinked section of guidewire was withdrawn through the device.Once removed the section of guidewire was passed through both sections of the device with no resistance noted.No issues were noted with the tip.

• 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: 8139122
• Report Number: 2134265-2018-63573
• Device Sequence Number: 2279662
• Product Code: FGE
• UDI-Device Identifier: 08714729793618
• UDI-Public: 08714729793618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 08/21/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022551850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1