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

Model Number	H74939135204010
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft break occurred.This 2mm x 40mm x 145cm coyote es balloon was selected for use during a tibial dilation procedure.During the procedure, the balloon catheter was found to be severed inside the introducer.The portion inside the introducer was successfully retrieved using forceps.The procedure was then completed using different devices.There were no patient complications.
Additional Manufacturer Narrative
Detailed event information was not provided to bsc.We completed a good faith effort to obtain the information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Detailed event information was not provided to bsc.We completed a good faith effort to obtain the information.If additional details become available, a supplemental report will be submitted.Device analysis findings: upon receipt at our post market quality assurance laboratory, the coyote es balloon catheter was examined both visually and microscopically.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined, and a separation was found at the hypotube 82.5 cm from the hub, along with multiple kinks along the shaft.No additional or other damages were observed upon further inspection.Product analysis confirmed the separation and kinks.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the coyote es device was completed and confirmed that the event of break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that a shaft break occurred.This 2mm x 40mm x 145cm coyote es balloon was selected for use during a tibial dilation procedure.During the procedure, the balloon catheter was found to be severed inside the introducer.The portion inside the introducer was successfully retrieved using forceps.The procedure was then completed using different devices.There were no patient complications.

• 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: 24619676
• Report Number: 2124215-2026-14698
• Device Sequence Number: 15986906
• Product Code: LIT
• UDI-Device Identifier: 08714729767190
• UDI-Public: (01)08714729767190(17)280826(10)37315694
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: H74939135204010
• Device Catalogue Number: H74939135204010
• Device Lot Number: 0037315694
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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 Age: 82 YR
• Patient Sex: Unknown