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

Model Number	H74939186301010
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve product status and additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that shaft leak occurred.A 3.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During balloon preparation, negative pressure was applied to evacuate air; however, the step could not be completed due to an apparent air leak.A hole was noted in the middle of the catheter shaft.After multiple attempts to resolve the issue, the balloon was replaced, and the procedure was completed using another device of the same type.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device eval by mfr: a coyote balloon catheter was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a hole in the guidewire lumen 10.7cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is damage to the device.
Event or Problem Description
It was reported that shaft leak occurred.A 3.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During balloon preparation, negative pressure was applied to evacuate air; however, the step could not be completed due to an apparent air leak.A hole was noted in the middle of the catheter shaft.After multiple attempts to resolve the issue, the balloon was replaced, and the procedure was completed using another device of the same type.There were no patient complications as a result of this event.

• 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: 24179124
• Report Number: 2124215-2026-04436
• Device Sequence Number: 18645982
• Product Code: LIT
• UDI-Device Identifier: 08714729796565
• UDI-Public: (01)08714729796565(17)271108(10)35247106
• Combination Product (Y/N): N
• 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,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 Model Number: H74939186301010
• Device Catalogue Number: H74939186301010
• Device Lot Number: 0035247106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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