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

Model Number	24704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel occlusion occurred.The target lesion was located in the peroneal artery.A 300cm v-14 control wire was advanced and placed into the lesion.However, during removal through the 3.0mm x 80mm x 150cm coyote balloon catheter lumen, the coating of the guidewire sheared off and was confirmed during visual inspection.Resistance was felt during removal of the wire through the balloon.The physician removed the balloon catheter.There was good distal run-off flow in the peroneal artery.After the intervention, the physician did another distal run-off of the peroneal artery to see if the coating occluded the vessel and it did.The physician performed balloon angioplasty where the coating was sitting and another run-off was performed.Good blood flow was established.The peeled off coating was not removed from the patient's body.The procedure was completed and the patient was sent home the same day.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that vessel occlusion occurred.The target lesion was located in the peroneal artery.A 300cm v-14 control wire was advanced and placed into the lesion.However, during removal through the 3.0mm x 80mm x 150cm coyote balloon catheter lumen, the coating of the guidewire sheared off and was confirmed during visual inspection.Resistance was felt during removal of the wire through the balloon.The physician removed the balloon catheter.There was good distal run-off flow in the peroneal artery.After the intervention, the physician did another distal run-off of the peroneal artery to see if the coating occluded the vessel and it did.The physician performed balloon angioplasty where the coating was sitting and another run-off was performed.Good blood flow was established.The peeled off coating was not removed from the patient's body.The procedure was completed and the patient was sent home the same day.

• 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: 10635666
• Report Number: 2134265-2020-13265
• Device Sequence Number: 2555290
• Product Code: DQY
• UDI-Device Identifier: 08714729796541
• UDI-Public: 08714729796541
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0025717726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention