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

Model Number 12TLW805F35

Device Problem Difficult to Flush (1251)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2022

Event Type  malfunction  

Event Description

Fogarty embolectomy catheter would not flush during preparation.The catheter was removed and replaced.No harm to the patient.

• Brand Name: FOGARTY
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13440478
• MDR Text Key: 284980079
• Report Number: 13440478
• 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: 02/01/2022

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: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 63942866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other