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

Model Number	H74939135302010
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft hole occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery.A 3mm x 20mm x 144cm coyote es balloon catheter was advanced over non-boston scientific guidewire for dilation.During the procedure, the shaft kinked and the wire broke through the wire lumen causing a pinhole on the shaft.The device was removed without any problems, and the procedure was completed with another of the same device.There was no patient complications noted as a result of this event.
Additional Manufacturer Narrative
H6 evaluation conclusion codes: updated from adverse event related to procedure, d1002 to adverse event related to patient condition, d1001.
Event or Problem Description
It was reported that shaft hole occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery.A 3mm x 20mm x 144cm coyote es balloon catheter was advanced over non-boston scientific guidewire for dilation.During the procedure, the shaft kinked and the wire broke through the wire lumen causing a pinhole on the shaft.The device was removed without any problems, and the procedure was completed with another of the same device.There was no patient complications noted 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: 22145097
• Report Number: 2124215-2025-34376
• Device Sequence Number: 8354002
• Product Code: LIT
• UDI-Device Identifier: 08714729767237
• UDI-Public: (01)08714729767237(17)270115(10)33214421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: H74939135302010
• Device Catalogue Number: H74939135302010
• Device Lot Number: 0033214421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 01/16/2024
• 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: GUIDE CATHETER: GUIDEZILLA; GUIDE CATHETER: GUIDEZILLA; GUIDEWIRE: CRUISE; GUIDEWIRE: CRUISE; INFLATION DEVICE: NIPRO; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: DESTINATION; INTRODUCER SHEATH: DESTINATION
• Patient Sex: Unknown