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

Model Number	120804F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: while using a fogarty embolectomy catheter the tip broke off in the patient.The tip was retrieved by the surgeon.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10147895
• Report Number: 10147895
• Device Sequence Number: 13994191
• Product Code: DXE
• UDI-Device Identifier: 00690103043303
• UDI-Public: (01)00690103043303
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 06/04/2020
• Report Date (Section F): 06/04/2020

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: 120804F
• Device Catalogue Number: 120804F
• Device Lot Number: 62766039
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 06/04/2020