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

Model Number	H74939135404010
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon broke internally, resulting in additional intervention.A coyote? es was selected for use in the right deep femoral artery.The patient had undergone previous operations in the lesion location, and the area was very sensitive.When the balloon was being withdrawn from the patient, the balloon broke at the junction of the guide exit area.The balloon guide was lost in the deep femoral artery.It was necessary to recover the device from the patient's circulation.There was a significant procedure delay of approximately 4 hours due to the medical scarpa approach used to recover the device.
Additional Manufacturer Narrative
Device analysis: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed a separation 26 cm from the tip and multiple kinks along the device shaft.Microscopic examination revealed no additional damages.
Event or Problem Description
It was reported that the balloon broke internally, resulting in additional intervention.A coyote? es was selected for use in the right deep femoral artery.The patient had undergone previous operations in the lesion location, and the area was very sensitive.When the balloon was being withdrawn from the patient, the balloon broke at the junction of the guide exit area.The balloon guide was lost in the deep femoral artery.It was necessary to recover the device from the patient's circulation.There was a significant procedure delay of approximately 4 hours due to the medical scarpa approach used to recover the device.

• 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: 22968788
• Report Number: 2124215-2025-62274
• Device Sequence Number: 9137901
• Product Code: LIT
• UDI-Device Identifier: 08714729767312
• UDI-Public: (01)08714729767312(17)271204(10)35421382
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: H74939135404010
• Device Catalogue Number: H74939135404010
• Device Lot Number: 0035421382
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown