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

Model Number 120404FP

Device Problems Melted (1385); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Received notification that batch of fogarty catheters are defective.Opened 11 catheters and every balloon melted and in pieces prior to even attempting to inflate them.Equipment desc: catheter 120404fp ca (10024600), supplier part 120404fp from edwards lifesciences (bcritc-p), catheter,embolectomy 4f sh 120404fp, catheter 120403fp ca (10066130), supplier part 120403fp from edwards lifesciences (bcritc-p), catheter,embolectomy 3f sh 120403.

• Brand Name: FOGARTY
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16146552
• MDR Text Key: 307194489
• Report Number: 16146552
• 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: 12/05/2022

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 Model Number: 120404FP
• Device Catalogue Number: 120404FP
• 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: 12/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1