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

Model Number	H74939185201510
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): dqy, lit.G4 - premarket / 510(k) #: k111295, k162350.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified popliteal artery.A 2.0mm x 150mm x 150cm coyote balloon was advanced for dilation.During the procedure, it was noted that the device was kinked, and the balloon ruptured during the first inflation at 16 atmospheres for 20 seconds.The device was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.

• 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: 21871544
• Report Number: 2124215-2025-24978
• Device Sequence Number: 15638917
• Product Code: DQY
• UDI-Device Identifier: 08714729796800
• UDI-Public: (01)08714729796800(17)270514(10)34026310
• 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
• Report Date (Section B): 04/21/2025

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: H74939185201510
• Device Catalogue Number: H74939185201510
• Device Lot Number: 0034026310
• 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: 04/07/2025
• Initial Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 05/14/2024
• 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