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

Model Number	H74939185301510
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k): k111295, k162350.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the guidewire was protruding near the balloon shaft exit port.The 100% stenosed target lesion was located in the moderately tortuous left anterior tibial artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.During removal, resistance was encountered, and the guidewire was observed protruding near the balloon shaft exit port.The balloon was removed along with the sheath, which appeared wavy.The procedure was completed using this device, and no patient complications occurred as a result of this event.
Additional Manufacturer Narrative
G4: premarket / 510(k): k111295, k162350.A coyote device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen and guidewire lumen were torn at the exit notch.There were multiple stretched segments 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 damage to the device.
Event or Problem Description
It was reported that the guidewire was protruding near the balloon shaft exit port.The 100% stenosed target lesion was located in the moderately tortuous left anterior tibial artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.During removal, resistance was encountered, and the guidewire was observed protruding near the balloon shaft exit port.The balloon was removed along with the sheath, which appeared wavy.The procedure was completed using this device, and no patient complications occurred as a result of this event.

• 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: 23865130
• Report Number: 2124215-2025-92316
• Device Sequence Number: 4618907
• Product Code: LIT
• UDI-Device Identifier: 08714729796947
• UDI-Public: (01)08714729796947(17)260523(10)31681717
• 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): 02/19/2026

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: 05/23/2026
• Device Model Number: H74939185301510
• Device Catalogue Number: H74939185301510
• Device Lot Number: 0031681717
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: CROSSLEAD.; GUIDEWIRE: CROSSLEAD.; INFLATION DEVICE: E-CHARGE.; INFLATION DEVICE: E-CHARGE.; INTRODUCER SHEATH: PARENT SELECT 4.5F.; INTRODUCER SHEATH: PARENT SELECT 4.5F.
• Patient Sex: Unknown