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	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 08/01/2025 as the exact event date was not reported.
Event or Problem Description
It was reported that balloon rupture occurred.4.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During procedure the balloon burst during inflation without reaching the burst rated pressure.The procedure was completed.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.4.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During procedure the balloon burst during inflation without reaching the burst rated pressure.The procedure was completed.There were no patient complications as a result of this event.It was further reported that the patient was treated for a peripheral arterial disease at the superficial femoral artery (sfa) for the sterling balloon and tibial artery for the coyote.The target lesion was approximately above 90% stenosis, not tortuous, and moderately to severely calcified.The balloon ruptured at the first inflation while taking the it up at below burst pressure.
Additional Manufacturer Narrative
B3 - date of event: date of event updated.

• 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: 23041763
• Report Number: 2124215-2025-64263
• Device Sequence Number: 21304684
• Product Code: LIT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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