MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24706
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 70% stenosed target lesion was located in the moderately calcified anterior tibial vessel on the right leg.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the procedure, the wire stuck in the lumen and the balloon started to technically almost like accordion in the body.The balloon and wire were pulled out.The wire has been replaced and completed the procedure with a different balloon.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.No issues were detected.There was an unknown guidewire stuck in the device.The inner shaft in the balloon was buckled down for 40mm starting at the proximal marker band and extending distally.The guidewire could not be removed from the buckled area.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment occurred.The 70% stenosed target lesion was located in the moderately calcified anterior tibial vessel on the right leg.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the procedure, the wire stuck in the lumen and the balloon started to technically almost like accordion in the body.The balloon and wire were pulled out.The wire has been replaced and completed the procedure with a different balloon.No patient complications were reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9396548
• Report Number: 2134265-2019-14741
• Device Sequence Number: 19581630
• Product Code: DQY
• UDI-Device Identifier: 08714729796466
• UDI-Public: 08714729796466
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• 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): 01/02/2020

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 Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0024417674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1