MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FOGARTY; CATHETER, EMBOLECTOMY

Model Number	120403F
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On attempting to pass the embolectomy catheter distally in the ulnar we were met with significant resistance pulling back and actually separated the tip of the embolectomy catheter.Had to cut down the ulnar artery to retrieve the tips of the catheters.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 22962746
• Report Number: 22962746
• Device Sequence Number: 13170724
• Product Code: DXE
• UDI-Device Identifier: 00690103043242
• UDI-Public: (01)00690103043242(17)270505(11)250203(10)66214389
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/22/2025
• Report Date (Section F): 08/22/2025

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: 120403F
• Device Catalogue Number: 120403F
• Device Lot Number: 66214389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• 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
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Date Report Sent to FDA: 08/22/2025