MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, PERCUTANEOUS

Model Number	H74939185302210
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire stuck occurred.The 100% stenosed target lesion was located in the severely tortuous and moderately calcified superficial femoral artery.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.A three coyote balloon was used during the procedure.After advancing a guidewire through the lesion.An ivus catheter was then introduced to the lesion but could not pass through and was subsequently removed.Additional dilation was performed using a coyote mr 3x220mm balloon, followed by thrombus aspiration.The lesion was assessed with ivus and re-dilated using the same coyote mr 3x220mm balloon.During this step, it was determined that a larger balloon was needed.A coyote mr 4x220mm balloon was prepared; however, while attempting to remove the coyote mr 3x220mm for replacement, the balloon could not be retrieved so the entire system was removed, and the procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that guidewire stuck occurred.The 100% stenosed target lesion was located in the severely tortuous and moderately calcified superficial femoral artery.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.A three coyote balloon was used during the procedure.After advancing a guidewire through the lesion.An ivus catheter was then introduced to the lesion but could not pass through and was subsequently removed.Additional dilation was performed using a coyote mr 3x220mm balloon, followed by thrombus aspiration.The lesion was assessed with ivus and re-dilated using the same coyote mr 3x220mm balloon.During this step, it was determined that a larger balloon was needed.A coyote mr 4x220mm balloon was prepared; however, while attempting to remove the coyote mr 3x220mm for replacement, the balloon could not be retrieved so the entire system was removed, and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual and microscopic examination revealed no damages.The unknown guidewire was able to be removed without any difficulties.Device to device interaction test was performed by tracking the device over a test 0.014 wire.There was no issue tracking over the guidewire.Inspection of the remaining components of the device revealed no additional damage or irregularities.Product analysis was unable to confirm the reported issue of the wire freezing or difficulty in removal.

• Brand Name: COYOTE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20967886
• Report Number: 2124215-2024-79428
• Device Sequence Number: 14483672
• Product Code: DQY
• UDI-Device Identifier: 08714729796961
• UDI-Public: 08714729796961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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 Model Number: H74939185302210
• Device Catalogue Number: H74939185302210
• Device Lot Number: 0033237145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown