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

Model Number	H74939186200610
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip fracture occurred resulting to patient complications.The target lesion was located in the mid anterior tibial artery.A 2.0mm x 60mm x 150cm, coyote balloon catheter was used for dilation.During the procedure, the tip of the angioplasty balloon fractured and became embedded in the arterial wall.A minor wire perforation was noted, accompanied by contrast extravasation, which resolved by the conclusion of the procedure.The device was simply removed from the patient in one piece, and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Sending this correction report to update the ar-device code from detachment of device or device component to break.
Event or Problem Description
It was reported that tip fracture occurred resulting to patient complications.The target lesion was located in the mid anterior tibial artery.A 2.0mm x 60mm x 150cm, coyote balloon catheter was used for dilation.During the procedure, the tip of the angioplasty balloon fractured and became embedded in the arterial wall.A minor wire perforation was noted, accompanied by contrast extravasation, which resolved by the conclusion of the procedure.The device was simply removed from the patient in one piece, and the procedure was completed with a different device.No patient complications were reported.It was further reported that the guidewire perforated the vessel.

• 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: 21304752
• Report Number: 2124215-2025-04994
• Device Sequence Number: 21044949
• Product Code: DQY
• UDI-Device Identifier: 08714729796732
• UDI-Public: 08714729796732
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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 Model Number: H74939186200610
• Device Catalogue Number: H74939186200610
• Device Lot Number: 0034161947
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/18/2025
• Date Device Manufactured: 06/04/2024
• 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