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

Model Number	H74939135152010
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft was detached, requiring intervention.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.The wire passed through the lesion and was widened with a 2.5mm x 20mm x 144cm coyote es balloon catheter.Subsequently, the shaft was moved to another lesion for plain old balloon angioplasty, but there was resistance encountered.Further inflation and deflation was performed, and the shaft was pulled.Upon pulling the shaft, it was confirmed that it was detached.A snare was used to retrieve the detached part, and no foreign objects were left in the body.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that shaft was detached, requiring intervention.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.The wire passed through the lesion, and was widened with a 2.5mm x 20mm x 144cm coyote es balloon catheter.Subsequently, the shaft was moved to another lesion for plain old balloon angioplasty, but there was resistance encountered.Further inflation and deflation was performed, and the shaft was pulled.Upon pulling the shaft, it was confirmed that it was detached.A snare was used to retrieve the detached part, and no foreign objects were left in the body.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that a 1.5mm x 20mm x 143cm coyote es balloon catheter was used during the procedure.
Additional Manufacturer Narrative
Updated d4 lot number: 0035411892 updated d4 expiration date: 12/03/2027 device evaluation by manufacturer: the coyote es balloon was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen and inflation lumen is separated 24.2cm from the tip.There are multiple kinks along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed a separation and damages that would have contributed to the difficulty to advance.

• 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: 22338978
• Report Number: 2124215-2025-39614
• Device Sequence Number: 21122090
• Product Code: LIT
• UDI-Device Identifier: 08714729767206
• UDI-Public: (01)08714729767206(17)280410(10)36286821
• 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,Followup
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939135152010
• Device Catalogue Number: H74939135152010
• Device Lot Number: 0035411892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown