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

Model Number 120403F

Device Problems Inflation Problem (1310); Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

One fogarty catheter was returned for evaluation without any attached components.Blood was visible on distal windings.The balloon was found to be ruptured around the circumference and the edges of the ruptured balloon latex were folded towards the inside of the balloon.After returning the balloon latex to the original position, the ruptured edges were not able to match up.No other visible damage or inconsistency to the catheter body and windings was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed for both lots and documented that the device met all specifications upon distribution.Customer report of balloon issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.It is common clinical practice to inspect all products before use.The instructions for use for the product contains the following statement: ¿as with all catheterization procedures, complications may occur.These may include local or systemic infection, local hematomas, intimal disruption, arterial dissection, perforation and vessel rupture, hemorrhage, arterial thrombosis, distal embolization of blood clots and atherosclerotic plaque, air embolus, aneurysm, arterial spasm, arteriovenous fistula formation, and balloon rupture with fragmentation, tip separation and distal embolization.¿ to minimize these risks, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.Balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.In this event, there were no patient complications noted.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 part of this monthly review.

Event Description

It was reported that the balloon of a fogarty arterial embolectomy catheter did not inflate at the balloon test before use.A tear was found on the balloon.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 ARTERIAL 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: 9365213
• MDR Text Key: 193326064
• Report Number: 2015691-2019-04378
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 10/15/2019

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 Expiration Date: 10/29/2020
• Device Model Number: 120403F
• Device Catalogue Number: 120403F
• Device Lot Number: 61471040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1