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

Model Number	H74939186301510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres for 10 seconds, the balloon ruptured.The device was removed, and a newly opened balloon was used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that balloon ruptured occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 3.0mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres for 10 seconds, the balloon ruptured.The device was removed, and a newly opened balloon was used to complete the procedure.No patient complications were reported.It was further reported that the target lesion was located in the distal sfa/popliteal artery.

• 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: 20724416
• Report Number: 2124215-2024-72694
• Device Sequence Number: 3850386
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: 08714729796589
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 12/01/2025
• Device Model Number: H74939186301510
• Device Catalogue Number: H74939186301510
• Device Lot Number: 0030638089
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/10/2024
• Date Device Manufactured: 12/02/2022
• 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