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

Model Number	24705
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
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 that the guidewire lumen is prolapsed and buckled 12.5cm from the tip.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the presence of damage that could have contributed to the reported difficulty to remove.
Event or Problem Description
It was reported that difficulty removal occurred.The 100% stenosed, 3.0mm x 250 target lesion was located in the mildly tortuous and multi-focal with moderately calcified proximal to mid anterior tibial artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was successfully inflated at 8 atmospheres for 30 seconds.However, during removal, there was a slight issue on the wire but was removed successfully.Procedure continued with atherectomy and when tried to post dilate with the balloon, it was noticed that the wire lumen portion twisted and kinked.The device was removed over the wire and a new 2.5x150x150 coyote balloon catheter was opened and the procedure was completed.There were no patient complications nor injuries 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: 12302043
• Report Number: 2134265-2021-09805
• Device Sequence Number: 3531953
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: 08714729796589
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 02/25/2024
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0026870964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 74