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

Model Number	H74939186301210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 3.0mm x 120mm x 150cm coyote balloon catheter was advanced for dilatation.During inflation, the balloon burst before it reached the normal burst pressure (nbp).The procedure was completed with another of same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 3.0mm x 120mm x 150cm coyote balloon catheter was advanced for dilatation.During inflation, the balloon burst before it reached the normal burst pressure (nbp).The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 100% stenosed, severely tortuous and non-calcified.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 3.0mm x 120mm x 150cm coyote balloon catheter was advanced for dilatation.During inflation, the balloon burst before it reached the normal burst pressure (nbp).The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 100% stenosed, severely tortuous and non-calcified.The device was returned for analysis, and the evaluation was completed on 12aug2025.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon was inflated to rated burst pressure (rbp) and was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22084721
• Report Number: 2124215-2025-33846
• Device Sequence Number: 7866774
• Product Code: DQY
• UDI-Device Identifier: 08714729796725
• UDI-Public: (01)08714729796725(17)271017(10)35084927
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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 Expiration Date: 05/24/2026
• Device Model Number: H74939186301210
• Device Catalogue Number: H74939186301210
• Device Lot Number: 0031690046
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 07/24/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 06/18/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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