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

Model Number	H74939135304010
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon ruptured and removal difficulty occurred.A 3mm x 40mm x 146cm coyote es was selected for use.During the procedure, the balloon ruptured in a calcified artery.During removal, part of the sheath remained caught on the guidewire and the tip of the balloon remained attached to the guidewire.Immediate action was performed by removing the guidewire from the patient.It was noted that the procedure was interrupted.There were minor consequences reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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: 25654049
• Report Number: 2124215-2026-34505
• Device Sequence Number: 5866378
• Product Code: LIT
• UDI-Device Identifier: 08714729767251
• UDI-Public: (01)08714729767251(17)290209(10)38562704
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: H74939135304010
• Device Catalogue Number: H74939135304010
• Device Lot Number: 0038562704
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2026
• 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: 06/02/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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