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

Model Number	H74939186401010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date as the event date was not provided.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the tibial artery.A 4.0mm x 100mm x 150cm coyote otw balloon catheter was advanced for dilatation.However, during first inflation without reaching the rated burst pressure, the balloon ruptured.The device was removed in one piece, and the procedure was completed with an alternate coyote balloon catheter.No patient complications reported, and the patient condition was stable post-procedure.

• Brand Name: COYOTE?
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22482070
• Report Number: 2124215-2025-43450
• Device Sequence Number: 20999781
• Product Code: DQY
• UDI-Device Identifier: 08714729797364
• UDI-Public: (01)08714729797364(17)260104(10)30792818
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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 Expiration Date: 01/04/2026
• Device Model Number: H74939186401010
• Device Catalogue Number: H74939186401010
• Device Lot Number: 0030792818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Date Device Manufactured: 01/05/2023
• 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