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

Model Number	H74939135304010
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on january 26, 2026.It was reported that the device was unable to load onto the guidewire.The target lesion was located in the superficial femoral artery.A 3mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.During the procedure, it was noted that the non-boston scientific guidewire could not cross the monorail lumen of coyote balloon.The coyote device was removed and exchanged, and the procedure was completed.There were no patient complications as a result of this event.However, returned device analysis revealed a shaft hole.
Additional Manufacturer Narrative
Device evaluated by mfr: the coyote es was returned for analysis and investigation was completed on 26jan2026.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed that the guidewire lumen was prolapsed with a hole 6.7 cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there was damage to the guidewire lumen.

• Brand Name: COYOTE? ES
• 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: 24415284
• Report Number: 2124215-2026-09815
• Device Sequence Number: 5879699
• Product Code: LIT
• UDI-Device Identifier: 08714729767251
• UDI-Public: (01)08714729767251(17)280108(10)35579368
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• 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
• Report Date (Section B): 02/23/2026

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: H74939135304010
• Device Catalogue Number: H74939135304010
• Device Lot Number: 0035579368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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
• Patient Sex: Unknown