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

Model Number	24705
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon device kinked and froze on the guide wire.The target lesion was located in moderately calcified and mildly tortious right tibialis anterior.The tibialis anterior was recanalized with a 300 cm v 14 control wire (guidewire).A 2.5mm x 120mm x 150cm coyote balloon was placed over the guidewire.Because of strong forces form the hard calcified vessel, the coyote kinked with the guidewire and no movement was possible.Forward and backward movements with the wire in the catheter were not possible.The devices were removed from the patient and it was noticed that a 3mm tip from the wire was missing.It was fixed by advancing another catheter in the vessel wall.Intervention was successfully finished and the patient status was well.It was noted that the cause of the event was related to the kink of the coyote balloon catheter.No additional patient complications were reported in relation to this event.
Event or Problem Description
It was reported that a balloon device kinked and froze on the guide wire.The target lesion was located in moderately calcified and mildly tortious right tibialis anterior.The tibialis anterior was recanalized with a 300 cm v 14 control wire (guidewire).A 2.5mm x 120mm x 150cm coyote balloon was placed over the guidewire.Because of strong forces form the hard calcified vessel, the coyote kinked with the guidewire and no movement was possible.Forward and backward movements with the wire in the catheter were not possible.The devices were removed from the patient and it was noticed that a 3mm tip from the wire was missing.It was fixed by advancing another catheter in the vessel wall.Intervention was successfully finished and the patient status was well.It was noted that the cause of the event was related to the kink of the coyote balloon catheter.No additional patient complications were reported in relation to this event.
Additional Manufacturer Narrative
The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a shaft kink 6mm proximal from the tip.There was blood in the inflation lumen and balloon.The balloon was tightly folded.Microscopic inspection revealed tip damage.There was a guidewire stuck inside the device which had torn the device from the tip to the distal marker band.The device was soaked in a water bath for one day to loosen the blood and contrast in the device.Guidewire was unable to be removed from the device due to the shaft kink.While taking images, the guidewire was damaged and separated near the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported guidewire difficulties.

• 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: 8784489
• Report Number: 2134265-2019-08062
• Device Sequence Number: 2044054
• Product Code: DQY
• UDI-Device Identifier: 08714729796527
• UDI-Public: 08714729796527
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111295
• 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,Followup
• Report Date (Section B): 08/05/2019

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: 05/08/2021
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0022094367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1