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

Model Number	H74939186202210
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch#: (b)(4) that occlusion occurred requiring additional intervention.The patient presented with reocclusion of the left superficial femoral artery (sfa) popliteal and anterior tibial artery one month following a previous atherectomy procedure.A 2.0mm x 220mm x 150cm coyote was used in the atherectomy procedure.The patient went for a follow up appointment due to leg pain for two days.The patient visited the emergency department, where a vascular ultrasound showed reocclusion of the left common femoral artery (cfa) and a potential foreign body in the right sfa extending from the mid sfa to the proximal popliteal artery.The patient underwent a repeat lower extremity angiogram the next day, followed by thrombectomy and angioplasty of the left sfa and tibial arteries.The foreign body was successfully removed from the patient.The retained foreign object matched with the outer covering of one of the balloons used during the initial angiogram.The object was not noticed on fluoroscopy during the initial procedure due to its transparent, radiolucent nature.No adverse outcomes occurred.
Additional Manufacturer Narrative
B3: date of event: event date was estimated, used the first date in the month of the date provided.
Event or Problem Description
It was reported via facility medwatch#: (b)(4) that occlusion occurred requiring additional intervention.The patient presented with reocclusion of the left superficial femoral artery (sfa) popliteal and anterior tibial artery one month following a previous atherectomy procedure.A 2.0mm x 220mm x 150cm coyote was used in the atherectomy procedure.The patient went for a follow up appointment due to leg pain for two days.The patient visited the emergency department, where a vascular ultrasound showed reocclusion of the left common femoral artery (cfa) and a potential foreign body in the right sfa extending from the mid sfa to the proximal popliteal artery.The patient underwent a repeat lower extremity angiogram the next day, followed by thrombectomy and angioplasty of the left sfa and tibial arteries.The foreign body was successfully removed from the patient.The retained foreign object matched with the outer covering of one of the balloons used during the initial angiogram.The object was not noticed on fluoroscopy during the initial procedure due to its transparent, radiolucent nature.No adverse outcomes occurred.It was further reported that the balloon protector was not removed from the coyote balloon during preparation, as it was late in the day and the room was dark.The physician and technician did not realize that the protector had not been removed.
Additional Manufacturer Narrative
B3: date of event: event date was estimated, used the first date in the month of the date provided.

• Brand Name: COYOTE
• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20841779
• Report Number: 2124215-2024-74328
• Device Sequence Number: 15449810
• Product Code: DQY
• UDI-Device Identifier: 08714729796466
• UDI-Public: 08714729796466
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: H74939186202210
• Device Catalogue Number: H74939186202210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 24 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White