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

Model Number	H74939185300810
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k)- k111295, k162350.
Event or Problem Description
It was reported that device entrapment occurred.The patient underwent angioplasty for occlusive arterial disease.A 3.0mm x 80mm x 150cm coyote balloon catheter was advanced for dilation over a pre-hydrated 014 guidewire.During introduction, the balloon was stuck on the guidewire and could not be removed.When traction force was applied, the balloon catheter was cut and got trapped on the guidewire.The balloon was deflated and removed, and the guidewire was withdrawn losing vascular access.The procedure was successfully completed another 3.0mm x 80mm x 150cm coyote balloon catheter.There were no patient complications as a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: 21980573
• Report Number: 2124215-2025-28327
• Device Sequence Number: 21028112
• Product Code: LIT
• UDI-Device Identifier: 08714729796916
• UDI-Public: (01)08714729796916(17)270731(10)34544101
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: H74939185300810
• Device Catalogue Number: H74939185300810
• Device Lot Number: 0034544101
• 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: 04/11/2025
• Initial Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 07/31/2024
• 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
• Patient Sex: Unknown