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

Model Number	H74939186201010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, patient information, and product return status, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a balloon rupture occurred.A 2.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.However, during inflation, the balloon burst without reaching the rated burst pressure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that a balloon rupture occurred.A 2.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During inflation, the balloon burst without reaching the rated burst pressure.It was further reported that the 99% stenosed target lesion was located in the non-tortuous and moderately calcified anterior tibial artery.During the procedure, the balloon ruptured upon first inflation for 20 seconds.The device was simply pulled out, and the procedure was completed with a different device.There were no patient complications as a result of this event.

• 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: 23251129
• Report Number: 2124215-2025-71542
• Device Sequence Number: 21436012
• Product Code: LIT
• UDI-Device Identifier: 08714729797135
• UDI-Public: (01)08714729797135(17)270510(10)34008524
• 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,Followup
• Report Date (Section B): 11/03/2025

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 Model Number: H74939186201010
• Device Catalogue Number: H74939186201010
• Device Lot Number: 0034008524
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 05/10/2024
• 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