MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F; CATHETER, EMBOLECTOMY

Model Number 120804F

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

The 4fr fogarty catheter was delivered to the sterile field, attempted to inflate the balloon with normal saline (ns) and it did not inflate.The ns leaked from the balloon site.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11912428
• MDR Text Key: 253556929
• Report Number: 11912428
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 120804F
• Device Catalogue Number: 120804F
• 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: 05/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA