MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, PERCUTANEOUS

Model Number	H74939186202210
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The previous atherectomy was performed one month prior to this event.Now, the patient presented with a reocclusion of the left superficial femoral artery (sfa) popliteal and anterior tibial artery.Patient went for a follow up appointment due to leg pain for two days.Patient presented to the emergency department after an evaluation at clinic with vascular ultrasound showing reocclusion of the left common femoral artery (cfa) and a possible foreign body in the right sfa extending from the mid sfa to the proximal popliteal artery.Patient underwent repeat lower extremity angiogram the next day, then patient underwent thrombectomy of the left sfa angioplasty and tibial arteries and successful retrieval of the foreign body.The preliminary report from interventional radiology indicated that the retained foreign object (rfo) was not a regular catheter they use for angiogram; it appeared to match with the outer covering of one of the balloons used during the first angiogram.It is not radiopaque, so it was not noticed on flouroscopy.The plastic cover is transparent and radiolucent, so by design that makes it a little difficult to visualize.Also, usually the lights are dimmed during an angiogram so that makes it trickier.No adverse outcome for patient.

• Brand Name: COYOTE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 20608986
• Report Number: 20608986
• Device Sequence Number: 7346498
• Product Code: DQY
• UDI-Device Identifier: 08714729796466
• UDI-Public: (01)08714729796466
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024
• Report Date (Section F): 11/04/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: H74939186202210
• Device Catalogue Number: H74939186202210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 11/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 24 KG
• Date Report Sent to FDA: 11/04/2024