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

Model Number	24706
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name-(b)(6) hospital.
Event or Problem Description
It was reported that device entrapment occurred.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified anterior tibial artery.A 2.5mm x 220mm x 150cm coyote balloon and a 300 cm, 18g victory 14 guidewire were selected for use.During the procedure, after an unsuccessful attempt to access the target lesion from the popliteal artery, the victory guidewire was taken out of the balloon to insert another wire.However, the tip of the wire became detached and got stuck in the hub.To dislodge the stuck tip, a saline solution was injected into the balloon and the back end of the victory guidewire was used to push out the detached tip in the balloon hub outside of the patient.Hence, the tip of the balloon was noticed to be kinked during removal.The procedure was completed with a different victory guidewire and a different coyote balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed buckling to the shaft inside the hub.Device to device interaction test was performed and a test guidewire could not pass through.The hub was x-ray and no guidewire was found inside the damaged section.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that would have contributed to the reported event.E1.Initial reporter facility name-(b)(6) hospital.
Event or Problem Description
It was reported that device entrapment occurred.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified anterior tibial artery.A 2.5mm x 220mm x 150cm coyote balloon and a 300 cm, 18g victory 14 guidewire were selected for use.During the procedure, after an unsuccessful attempt to access the target lesion from the popliteal artery, the victory guidewire was taken out of the balloon to insert another wire.However, the tip of the wire became detached and got stuck in the hub.To dislodge the stuck tip, a saline solution was injected into the balloon and the back end of the victory guidewire was used to push out the detached tip in the balloon hub outside of the patient.Hence, the tip of the balloon was noticed to be kinked during removal.The procedure was completed with a different victory guidewire and a different coyote balloon.There were no patient complications reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18584684
• Report Number: 2124215-2024-00502
• Device Sequence Number: 12890981
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 08/01/2026
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0032135344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: Male
• Patient Race: White