MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, PERCUTANEOUS

Model Number	H74939185401010
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): dqy, lit.
Event or Problem Description
It was reported that balloon damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, upon unpacking the device, it was observed that the tip of the balloon was torn.The procedure was then completed using another device of the same type.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, upon unpacking the device, it was observed that the tip of the balloon was torn.The procedure was then completed using another device of the same type.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): dqy, lit.The device was returned for analysis and underwent visual and microscopic examination of the outer shaft, inner shaft, balloon, and tip.Visual inspection revealed a tear in the balloon located approximately 11 mm from the distal tip.Microscopic evaluation did not identify any additional damage or anomalies beyond the observed balloon tear.Examination of the remaining components showed no other signs of damage or irregularities.Product analysis confirmed the presence of a tear in a portion of the balloon.

• Brand Name: COYOTE
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 21789962
• Report Number: 2124215-2025-20892
• Device Sequence Number: 15660938
• Product Code: LIT
• UDI-Device Identifier: 08714729797067
• UDI-Public: (01)08714729797067(17)271105(10)35216486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: H74939185401010
• Device Catalogue Number: H74939185401010
• Device Lot Number: 0035216486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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