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

Model Number 120804FP

Device Problem Material Disintegration (1177)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2023

Event Type  malfunction  

Event Description

This has appeared to be an ongoing issue with the fogarty catheters.The balloon appears to be disintegrating/dry rotting.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16466585
• MDR Text Key: 310506613
• Report Number: 16466585
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2023

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 Operator: Health Professional
• Device Model Number: 120804FP
• Device Catalogue Number: 120804FP
• Device Lot Number: 63611721
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1