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

Model Number	H74939186200810
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the balloon was stuck on wire.A 2.0mm x 80mm x 150cm, coyote was selected for use in angioplasty.During the procedure, the balloon catheter became stuck and could not be advanced or the wire removed independently.The physician was required to withdraw the wire and balloon catheter together.Upon removal, the balloon catheter appeared stretched.The device was removed using normal method without issue and the procedure was completed with alternate device used.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the coyote device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple buckling along the shaft.Microscopic examination revealed no additional damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a guidewire stuck in the device.
Event or Problem Description
It was reported the balloon was stuck on wire.A 2.0mm x 80mm x 150cm, coyote was selected for use in angioplasty.During the procedure, the balloon catheter became stuck and could not be advanced or the wire removed independently.The physician was required to withdraw the wire and balloon catheter together.Upon removal, the balloon catheter appeared stretched.The device was removed using normal method without issue and the procedure was completed with alternate device used.There were no patient complications as a result of this event.

• 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: 23255815
• Report Number: 2124215-2025-70132
• Device Sequence Number: 10168094
• Product Code: LIT
• UDI-Device Identifier: 08714729796428
• UDI-Public: (01)08714729796428(17)270205(10)33362264
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/20/2025

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: H74939186200810
• Device Catalogue Number: H74939186200810
• Device Lot Number: 0033362264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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