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

Model Number	H74939134204010
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon failed to deflate.The target lesion was located in the very distal right anterior tibial artery.A 2mm x 40mm x 144cm coyote es balloon catheter was selected for angiogram with intervention.However, it was noted that the balloon showed a dark contrast when inflated and had difficulty deflating.Multiple attempts were made to burp the in deflator and using a 3cc syringe to add additional pressure to decompress the balloon.After several attempts for 5-7 minutes.The balloon finally deflated after manually milking it.Angiogram revealed no damage to vessel and positive results from the balloon.The procedure was completed with this device.There were no patient complications as a result of this event, and the patient fully recovered post-procedure.
Event or Problem Description
It was reported that the balloon failed to deflate.The target lesion was located in the very distal right anterior tibial artery.A 2mm x 40mm x 144cm coyote es balloon catheter was selected for angiogram with intervention.However, it was noted that the balloon showed a dark contrast when inflated and had difficulty deflating.Multiple attempts were made to burp the in deflator and using a 3cc syringe to add additional pressure to decompress the balloon.After several attempts for 5-7 minutes.The balloon finally deflated after manually milking it.Angiogram revealed no damage to vessel and positive results from the balloon.The procedure was completed with this device.There were no patient complications as a result of this event, and the patient fully recovered post-procedure.It was further reported that the ballon was inflated for 6 atmospheres, and it took 5 -7 min for the balloon to deflate and be removed from the patient.The balloon was fully deflated during removal.According to the physician, the visibility of the balloon on angiography indicated that the ratio of contrast to saline was incorrect.Also, the balloon was inflated in the distal target lesion, which is challenging due to the distance and the size of the vessel.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon was functionally tested by inflating it to rated burst pressure and then deflated.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon failed to deflate.The target lesion was located in the very distal right anterior tibial artery.A 2mm x 40mm x 144cm coyote es balloon catheter was selected for angiogram with intervention.However, it was noted that the balloon showed a dark contrast when inflated and had difficulty deflating.Multiple attempts were made to burp the in deflator and using a 3cc syringe to add additional pressure to decompress the balloon.After several attempts for 5-7 minutes.The balloon finally deflated after manually milking it.Angiogram revealed no damage to vessel and positive results from the balloon.The procedure was completed with this device.There were no patient complications as a result of this event, and the patient fully recovered post-procedure.It was further reported that the balloon was inflated for 6 atmospheres, and it took 5 -7 min for the balloon to deflate and be removed from the patient.The balloon was fully deflated during removal.According to the physician, the visibility of the balloon on angiography indicated that the ratio of contrast to saline was incorrect.Also, the balloon was inflated in the distal target lesion, which is challenging due to the distance and the size of the vessel.

• 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: 23818517
• Report Number: 2124215-2025-91135
• Device Sequence Number: 18466508
• Product Code: LIT
• UDI-Device Identifier: 08714729767350
• UDI-Public: (01)08714729767350(17)270217(10)35871282
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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: H74939134204010
• Device Catalogue Number: H74939134204010
• Device Lot Number: 0035871282
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/12/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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 Age: 69 YR
• Patient Sex: Male