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

Model Number	H74939185201510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 - premarket / 510(k): k111295, k162350.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified vessel of below the knee.A 2.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.During the first inflation at 7 atmospheres for 2 seconds, the balloon ruptured from a pinhole at near the balloon shoulder.The device was removed using normal method without issue and the procedure was completed with a different device.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: 23658734
• Report Number: 2124215-2025-86928
• Device Sequence Number: 10027435
• Product Code: LIT
• UDI-Device Identifier: 08714729796800
• UDI-Public: (01)08714729796800(17)280428(10)36405544
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: 0036405544
• 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: 11/14/2025
• Initial Report FDA Received Date: 11/26/2025
• Date Device Manufactured: 04/29/2025
• 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: JUPITER; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: DESTINATION 6F; MICRO CATHETER: ARMET
• Patient Sex: Unknown