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

Model Number	H74939185300610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified vessel.A 3.0mm x 60mm x 150cm coyote balloon catheter was advanced for dilation.During third inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was removed successfully from the patient and the procedure was completed with a new balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): dqy, lit.G4 - premarket / 510(k): k111295, k162350.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified vessel.A 3.0 mm x 60 mm x 150 cm coyote balloon catheter was advanced for dilation.During third inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was removed successfully from the patient and the procedure was completed with a new balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): dqy, lit.G4: premarket/510(k): k111295, k162350.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 no damages.Microscopic examination revealed a pinhole 10 mm from the tip.No other issues were identified during the product analysis.

• 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: 21882011
• Report Number: 2124215-2025-25303
• Device Sequence Number: 15613568
• Product Code: DQY
• UDI-Device Identifier: 08714729796268
• UDI-Public: (01)08714729796268(17)270412(10)33813071
• 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): 05/15/2025

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: H74939185300610
• Device Catalogue Number: H74939185300610
• Device Lot Number: 0033813071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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