MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939186350610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and severely calcified vessel.A 3.5mm x 60mm x 150cm coyote balloon catheter was selected for left leg angiogram.During the procedure, the balloon ruptured upon third inflation at 14 atmospheres for 3 seconds.There were no device fragments left inside the patient.The device was removed without any problem, and the procedure was completed with original method/device used.There were no patient complications as result of the event.
Additional Manufacturer Narrative
Device evaluated by mfr: the coyote was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed the balloon had a rupture.Microscopic examination revealed that the balloon ruptured longitudinal.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and severely calcified vessel.A 3.5mm x 60mm x 150cm coyote balloon catheter was selected for left leg angiogram.During the procedure, the balloon ruptured upon third inflation at 14 atmospheres for 3seconds.There were no device fragments left inside the patient.The device was removed without any problem, and the procedure was completed with original method/device used.There were no patient complications as result of the event.It was further reported that the target lesion was located in the left leg.

• Brand Name: COYOTE?
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 23438857
• Report Number: 2124215-2025-78342
• Device Sequence Number: 20970407
• Product Code: LIT
• UDI-Device Identifier: 08714729797289
• UDI-Public: (01)08714729797289(17)261012(10)32629456
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: H74939186350610
• Device Catalogue Number: H74939186350610
• Device Lot Number: 0032629456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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 Sex: Unknown