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

Model Number	H74939135404010
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.During the initial inflation at 12 atmospheres for 3 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.During the initial inflation at 12 atmospheres for 3 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: upon receipt at our post market quality assurance laboratory, this coyote es device was examined.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the shaft 63mm from the tip.Microscopic examination revealed a hole in the guidewire lumen at the buckling.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that would have contributed to the reported balloon rupture.No other issues were identified during the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Conclusion based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as unintended use error caused or contributed to event.

• Brand Name: COYOTE? ES
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24341480
• Report Number: 2124215-2026-08400
• Device Sequence Number: 18222286
• Product Code: LIT
• UDI-Device Identifier: 08714729767312
• UDI-Public: (01)08714729767312(17)281102(10)37855955
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• 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,Followup
• Report Date (Section B): 04/22/2026

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: H74939135404010
• Device Catalogue Number: H74939135404010
• Device Lot Number: 0037855955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/15/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• 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
• Patient Sex: Unknown