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

Model Number	H74939135402010
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter separated, requiring intervention.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5f non-boston scientific (bsc) sheath and non-bsc guidewire were inserted along with the 4 mm x 20 mm x 144 cm coyote es balloon catheter.The coyote was being used as an anchor to advance a 6f non-boston scientific (bsc) sheath from an antegrade to a more distal position.During the procedure, the coyote catheter became trapped in the severe calcification, and when strongly pulled, the catheter separated inside the patient at about 20 cm from the distal tip.There was no reported resistance when the balloon was pulled out.The coyote catheter was removed by puncturing the dorsalis pedis artery and inserting an unknown balloon catheter from the retrograde and pushing out the coyote.The detached fragment was removed outside the body.The procedure was completed with a different device.No complications were reported, and there was no problem with the patient after the surgery.
Event or Problem Description
It was reported that the catheter separated, requiring intervention.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5f non-boston scientific (bsc) sheath and non-bsc guidewire were inserted along with the 4mm x 20mm x 144cm coyote es balloon catheter.The coyote was being used as an anchor to advance a 6f non-boston scientific (bsc) sheath from an antegrade to a more distal position.During the procedure, the coyote catheter became trapped in the severe calcification, and when strongly pulled, the catheter separated inside the patient at about 20cm from the distal tip.There was no reported resistance when the balloon was pulled out.The coyote catheter was removed by puncturing the dorsalis pedis artery and inserting an unknown balloon catheter from the retrograde and pushing out the coyote.The detached fragment was removed outside the body.The procedure was completed with a different device.No complications were reported, and there was no problem with the patient after the surgery.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft was separated 25cm 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 the shaft was separated.

• 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: 21314282
• Report Number: 2124215-2025-02787
• Device Sequence Number: 18180403
• Product Code: LIT
• UDI-Device Identifier: 08714729767299
• UDI-Public: 08714729767299
• 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): 03/04/2025

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 Expiration Date: 05/07/2026
• Device Model Number: H74939135402010
• Device Catalogue Number: H74939135402010
• Device Lot Number: 0031570337
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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: CROSSLEAD PENETRATION; GUIDEWIRE: CROSSLEAD PENETRATION; INTRODUCER SHEATH: 6F DESTINATION 45CM; INTRODUCER SHEATH: 6F DESTINATION 45CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown