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

Model Number	24705
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target location was located in the moderate calcified vein.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, the balloon did not inflate and when explanted, a tear was noted.Another 2.0mm x 120mm x 150cm coyote balloon was used and it burst upon second inflation at 6 atmospheres.The device was removed without any problem, and the procedure was completed with alternative method.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target location was located in the moderate calcified vein.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, the balloon did not inflate and when explanted, a tear was noted.Another 2.0mm x 120mm x 150cm coyote balloon was used and it burst upon second inflation at 6 atmospheres.The device was removed without any problem, and the procedure was completed with alternative method.No patient complications were reported.It was further review reported the device was simply pulled out and that no fragments inside the patient's body.
Event or Problem Description
It was reported that balloon rupture occurred.The target location was located in the moderate calcified vein.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, the balloon did not inflate and when explanted, a tear was noted.Another 2.0mm x 120mm x 150cm coyote balloon was used and it burst upon second inflation at 6 atmospheres.The device was removed without any problem, and the procedure was completed with alternative method.No patient complications were reported.It was further review reported the device was simply pulled out and that no fragments inside the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr: the coyote was returned for analysis.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination showed no issues.Functional testing was completed by using an inflations device filled with water to inflate and hold water at nominal pressure.The balloon held pressure and was deflated with no issues.

• 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: 19960202
• Report Number: 2124215-2024-49325
• Device Sequence Number: 15238063
• Product Code: DQY
• UDI-Device Identifier: 08714729796534
• UDI-Public: 08714729796534
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 02/09/2026

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: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0032704242
• 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: 07/21/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 01/14/2026
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/05/2024; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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: Male