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

Model Number	24705
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age of time of event: 18yrs or older.
Event or Problem Description
It was reported that catheter entrapment occurred.The 50% stenosed target lesion was located in the non-tortuous and mildly calcified right anterior tibial artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced onto the 014 300cm thruway guidewire for dilatation.However, the balloon and the guidewire were stuck together.The two devices were completely removed from the patient's body and the procedure was completed with a new wire and another of the same balloon.There were no patient complications reported.
Event or Problem Description
It was reported that catheter entrapment occurred.The 50% stenosed target lesion was located in the non-tortuous and mildly calcified right anterior tibial artery.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced onto the.014, 300cm thruway guidewire for dilatation.However, the balloon and the guidewire were stuck together.The two devices were completely removed from the patient's body and the procedure was completed with a new wire and another of the same balloon.There were no patient complications reported.It was further reported that when the physician realized there was an issue advancing the balloon, they tried pulling the balloon back over the wire and also simply pulling the wire.When these attempts failed, the system was pulled.
Additional Manufacturer Narrative
Age of time of event: 18yrs or older.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 tightly folded.Microscopic inspection revealed tip damage.The balloon was buckled starting at the proximal end and extending 7.5cm distally.A guidewire was inside the device and was able to be removed out the distal end of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8902359
• Report Number: 2134265-2019-09314
• Device Sequence Number: 18892921
• Product Code: DQY
• UDI-Device Identifier: 08714729796459
• UDI-Public: 08714729796459
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 08/30/2019

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: 04/10/2022
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0023628563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1