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

Catalog Number 120803F

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/24/2019

Event Type  malfunction  

Event Description

A 3fr fogarty embolectomy catheter was being used for a mechanical arterial thrombectomy.During the procedure, a metal spiral fragment broke off and was identified and removed from the patient.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9139590
• MDR Text Key: 160710946
• Report Number: 9139590
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/12/2019,09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 120803F
• Device Lot Number: 62333363
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 78