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

Model Number	H74939134254010
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon became stuck with the wire.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified peripheral artery.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.During the procedure, the balloon became stuck with the non-boston scientific wire before it entered the patient's body.The device was removed together with the wire and the guidewire was able to be removed from the balloon once outside the patient, and the procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the coyote es with a 0.014 guidewire inside the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple buckling along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the froze on wire.No other issues were identified with the device.
Event or Problem Description
It was reported that the balloon became stuck with the wire.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified peripheral artery.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.During the procedure, the balloon became stuck with the non-boston scientific wire before it entered the patient's body.The device was removed together with the wire and the guidewire was able to be removed from the balloon once outside the patient, and the procedure was completed using an alternate device.There were no patient complications as a result of this event.

• Brand Name: COYOTE ES
• 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: 21751930
• Report Number: 2124215-2025-19499
• Device Sequence Number: 18567134
• Product Code: LIT
• UDI-Device Identifier: 08714729767381
• UDI-Public: (01)08714729767381(17)260709(10)34394438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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 Expiration Date: 07/09/2026
• Device Model Number: H74939134254010
• Device Catalogue Number: H74939134254010
• Device Lot Number: 0034394438
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 014 COMMAND WIRE; 014 COMMAND WIRE
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White