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

Model Number	24704
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date approximated to (b)(6) 2021 based on date boston scientific was made aware of this event.Device returned and evaluated by manufacturer.Returned device consisted of a coyote balloon catheter with an unknown 0.014" guidewire stuck inside of it.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed multiple buckling to the guidewire lumen and the tip is damaged.Product analysis found damage to the device that would have contributed to the reported difficulty to track over wire.
Event or Problem Description
Reportable based on device analysis completed on 27jul2021.It was reported that the catheter could not move over the guidewire.A 2.5x80x150 coyote balloon was selected for a procedure.During the procedure, it was reported that the coyote was not able to move over the.014 v-14 guidewire.There were no patient complications reported.No patient complications were reported and the procedure was completed successfully using an alternate device.However, device analysis revealed that an unknown.014 wire was stuck in the catheter.

• 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: 12336029
• Report Number: 2134265-2021-10465
• Device Sequence Number: 20078819
• Product Code: DQY
• UDI-Device Identifier: 08714729797180
• UDI-Public: 08714729797180
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 02/05/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0026758044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1