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

Model Number	H74939186302210
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993); Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that froze on wire occurred.The 65% stenosed target lesion was located in the mild tortuous and mild calcified vessel in the right leg.A 3.0mm x 220mm x 150cm coyote was selected for use.During the procedure, a.014 non boston scientific guidewire was advanced from an up and over approach through a non boston scientific sheath.A.014 non-boston scientific ivus catheter was loaded but would not advance through the lesion.The ivus catheter was removed.The coyote was advanced for dilation.It was noted that there were no balloon marker-bands showing up on the x-ray screen.The physician moved the x-ray north, towards the head and noticed that the wire had prolapsed on itself and the balloon was not advancing.Upon attempting to remove the balloon, it would not come out of the body without taking the non-boston wire with it.After removal, it was observed that the balloon was fused to the wire and would not come out, even with excessive force.The procedure was completed with alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that froze on wire occurred.The 65% stenosed target lesion was located in the mild tortuous and mild calcified vessel in the right leg.A 3.0mm x 220mm x 150cm coyote was selected for use.During the procedure, a.014 non boston scientific guidewire was advanced from an up and over approach through a non boston scientific sheath.A.014 non-boston scientific ivus catheter was loaded but would not advance through the lesion.The ivus catheter was removed.The coyote was advanced for dilation.It was noted that there were no balloon marker-bands showing up on the x-ray screen.The physician moved the x-ray north, towards the head and noticed that the wire had prolapsed on itself and the balloon was not advancing.Upon attempting to remove the balloon, it would not come out of the body without taking the non-boston wire with it.After removal, it was observed that the balloon was fused to the wire and would not come out, even with excessive force.The procedure was completed with alternate device.There were no patient complications as a result of this event.It was further reported that the radio opaque markers were not seen because they never made it to the lesion, not because they were having trouble visualizing.
Additional Manufacturer Narrative
B5: describe event or problem: updated good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr: the coyote was returned for analysis.The balloon was received with the guidewire stuck.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed bunching on the inner shaft at the balloon area.It was also noted that there was a separation at the tip of the inner shaft.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 24249169
• Report Number: 2124215-2026-06119
• Device Sequence Number: 15530989
• Product Code: LIT
• UDI-Device Identifier: 08714729797265
• UDI-Public: (01)08714729797265(17)281020(10)37754662
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/04/2026

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: H74939186302210
• Device Catalogue Number: H74939186302210
• Device Lot Number: 0037754662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - .014 TERUMO.; GUIDEWIRE - .014 TERUMO.; IVUS CATHETER - .014 PHILIPS VOLCANO.; IVUS CATHETER - .014 PHILIPS VOLCANO.; SHEATH - MEDTRONIC APTUS STEERABLE.; SHEATH - MEDTRONIC APTUS STEERABLE.
• Patient Sex: Unknown