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

Model Number	24704
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the left tibioperoneal trunk (tpt).A 3.0mm x 80mm x 150cm coyote balloon catheter was advanced for dilation.However, when the balloon catheter was advanced down the 014 thruway 300cm/short taper/straight wire, it was noted that as the balloon got closer to the tip of the wire, the wire became stuck in the wire lumen of the balloon.The wire was attempted to be removed but failed; then both the wire and balloon were removed together and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the left tibioperoneal trunk (tpt).A 3.0mm x 80mm x 150cm coyote balloon catheter was advanced for dilation.However, when the balloon catheter was advanced down the 014 thruway 300cm/short taper/straight wire, it was noted that as the balloon got closer to the tip of the wire, the wire became stuck in the wire lumen of the balloon.The wire was attempted to be removed but failed; then both the wire and balloon were removed together and the procedure was completed with a different device.There were no patient complications nor injuries reported.
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 that the guidewire lumen is buckled in multiple locations and there is a pinhole in the balloon 9mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that may have contributed to the reported event.

• 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: 12189574
• Report Number: 2134265-2021-09178
• Device Sequence Number: 17094340
• Product Code: DQY
• UDI-Device Identifier: 08714729796541
• UDI-Public: 08714729796541
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 08/26/2021

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: 03/01/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0026899598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1