MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Coyote? ES; Catheter, Angioplasty, Peripheral, Transluminal

Model Number	H74939135202010
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	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured, and the procedure was cancelled.A 2mm x 40mm x 145cm coyote? es balloon catheter was selected for use in a femoro-popliteal left leg crossover angioplasty procedure.The patient had vascular calcifications.After dilation, the balloon ruptured during its removal.The device was replaced with a 2mm x 20mm x 143cm coyote? es balloon catheter, and the same problem occurred.Both balloons were successfully removed from the body.The procedure was cancelled.There were no patient complications as a result of this 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 ; +1(763)494-1632
• MDR Report Key: 25477435
• Report Number: 2124215-2026-31324
• Device Sequence Number: 21123340
• Product Code: LIT
• UDI-Device Identifier: 08714729767176
• UDI-Public: (01)08714729767176(17)280930(10)37597129
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: H74939135202010
• Device Catalogue Number: H74939135202010
• Device Lot Number: 0037597129
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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: 78 YR
• Patient Sex: Unknown