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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.A 3.0mm x 60mm x 150cm coyote balloon catheter was selected for use; however, the balloon catheter became stuck on the guidewire.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of a coyote balloon catheter with an unidentified guide wire.The balloon was loosely folded.The guide wire outer diameter was measured to be.0136".Analysis of the tip, balloon, and inner/outer shaft included microscopic and visual inspection.Inspection revealed tip damage, balloon material damage (hole/perforations) in the distal cone area, balloon/inner shaft damage (buckling) for a length of 10.9cm that started approximately 5mm from the tip of the device.Inspection of the rest of the device found no other damage or defects.The wire was attempted to be removed from the catheter, but the wire was firmly stuck in the damaged inner shaft.Review of the product specification indicates the coyote is compatible with a.014" guide wire.The reported information indicates the coyote was used with a.0136" guide wire; therefore, there is no indication of a compatibility issue.
Event or Problem Description
It was reported that catheter entrapment occurred.A 3.0mm x 60mm x 150cm coyote balloon catheter was selected for use; however, the balloon catheter became stuck on the guidewire.No patient complications were 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: 11036776
• Report Number: 2134265-2020-18047
• Device Sequence Number: 16405852
• Product Code: DQY
• UDI-Device Identifier: 08714729797227
• UDI-Public: 08714729797227
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/12/2021

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: 10/23/2022
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0024650607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1