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

Model Number	H74939186301010
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified vessel.A 3.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During advancing through the guidewire, the balloon catheter became stuck.Upon removal, it was noted that the balloon's middle section broke in two pieces.The procedure successfully completed using original method and/or device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 5.5cm and 22cm from the tip.The inflation lumen is separated 26.8cm from the tip.Microscopic examination revealed no additional damages.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified vessel.A 3.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.During advancing through the guidewire, the balloon catheter became stuck.Upon removal, it was noted that the balloon's middle section broke in two pieces.The procedure successfully completed using original method and/or device.No patient complications were reported.

• 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: 20847107
• Report Number: 2124215-2024-72257
• Device Sequence Number: 3838817
• Product Code: DQY
• UDI-Device Identifier: 08714729796565
• UDI-Public: (01)08714729796565(17)261011(10)32620726
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: H74939186301010
• Device Catalogue Number: H74939186301010
• Device Lot Number: 0032620726
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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