MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; FOGARTY CATHETER

Model Number 12TLW804F

Device Problems Break (1069); Crack (1135); Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.This complaint involves a fracture of the tubing near the tip of the catheter.If the fracture was not detected prior to use and the catheter was used, there is a potential for the tip to separate if the balloon material fractured as well.There is a low likelihood of fragment embolization because these devices are primarily used in occluded vessels.A detachment will however require a percutaneous intervention to retrieve the detached fragment in order to prevent long term complications.It is stated in the ifu that ¿the catheter should be inspected with the balloon inflated during purging.¿ there were no patient complications reported as the cracked tip was found before use.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

Event Description

It was reported that the tip of a fogarty thru-lumen embolectomy catheter was found cracked before use.There were no patient complications reported.Patient demographic information requested but unavailable.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8698132
• MDR Text Key: 148305861
• Report Number: 2015691-2019-02161
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12TLW804F
• Device Catalogue Number: 12TLW804F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1