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

Model Number	H74939185301510
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k) #: k111295, k162350.Device evaluated by mfr.The coyote device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damage.Microscopic examination revealed a pinhole 38mm from the tip.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that balloon failed to inflate.The target lesion was located in a severely calcified anterior tibial artery.A 3.0 mm x 150 mm x 150 cm coyote balloon catheter was selected for use in a percutaneous transluminal angioplasty.During the procedure, it was noted that the balloon catheter was not fully expanded well.The procedure was completed with this device.There were no patient complications as a result of this event.However, device analysis revealed a balloon pinhole.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23531965
• Report Number: 2124215-2025-82101
• Device Sequence Number: 15724333
• Product Code: LIT
• UDI-Device Identifier: 08714729796947
• UDI-Public: (01)08714729796947(17)260813(10)32207950
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 11/12/2025

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: 08/13/2026
• Device Model Number: H74939185301510
• Device Catalogue Number: H74939185301510
• Device Lot Number: 0032207950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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 Age: 66 YR
• Patient Sex: Male