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

Model Number	H74939135204010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.During endovascular treatment (evt) of a chronic total occlusion (cto) lesion, a 2.0 mm x 40 mm coyote balloon catheter was advanced following guidewire passage.However, due to the highly calcified lesion, the balloon ruptured during the first inflation at 8 atmospheres.Dilatation was continued using a high-pressure (hp) balloon of the same size, followed by a 2.5 mm x 150 mm coyote balloon catheter.During the second inflation at 6 atmospheres, the second coyote balloon also ruptured.The procedure was completed using a high-pressure balloon of the same size followed by post-dilatation with a 3 mm high-pressure balloon.No patient complications were reported 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: 25874044
• Report Number: 2124215-2026-38719
• Device Sequence Number: 12774264
• Product Code: LIT
• UDI-Device Identifier: 08714729767190
• UDI-Public: (01)08714729767190(17)290209(10)38562700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• 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: H74939135204010
• Device Catalogue Number: H74939135204010
• Device Lot Number: 0038562700
• Was Device Available for Evaluation?: No
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 02/10/2026
• 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