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

Model Number	120403F
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor asked for short 3f fogarty balloon.It was given to sterile scrub and was inspected by doctor and intact.After use it was apparent that the balloon end of the catheter was no longer attached and was unable to be located on the sterile field.Fogarty was passed proximal in the superior mesenteric artery.Of note, on the last proximal pass of the fogarty the balloon appears to have broken and could not be found.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16750948
• Report Number: 16750948
• Device Sequence Number: 19652566
• Product Code: DXE
• UDI-Device Identifier: 00690103043242
• UDI-Public: (01)00690103043242(17)250219(11)221121(10)64703421
• 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): 03/30/2023
• Report Date (Section F): 03/30/2023

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
• Device Model Number: 120403F
• Device Catalogue Number: 120403F
• Device Lot Number: 64703421
• 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: 04/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2023
• 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 Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 03/30/2023