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

Model Number 12TLW405F35

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Material Rupture (1546)

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

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

One fogarty thru-lumen embolectomy catheter without any attached components was returned for evaluation.A tear, <0.5mm in size, was found near the proximal windings and the edges of the torn latex did not appear to match up.No other visible damage was observed from the catheter body or windings.The balloon inflation lumen and thru-lumen were found to be completely occluded.A cut down of the catheter body was performed and an unknown clear viscous material was found in the entire balloon inflation lumen and an unknown clear material was found located 25.5 cm proximal from the catheter tip in the thru-lumen.The material at both locations was removed and sent to chemistry for analysis.Balloon testing performed with lab syringe.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon issue was confirmed.A supplemental report will be sent with the chemistry investigation results.

Event Description

It was reported that sterile fluid leaked from the balloon of the fogarty catheter and the balloon did not inflate during testing before use.There were no patient complications reported.Patient demographic information requested but unavailable.

Manufacturer Narrative

Two samples (unknown clear material found in the balloon inflation lumen and unknown clear material found in the through lumen) were sent to chemistry for ir spectrum testing.The ir spectrum of the unknown clear material in the balloon inflation lumen showed similar absorption characteristics when comparing to polyester-like material.This substance is used during the catheter manufacturing process as the balloon winding threads are made of polyester.The ir spectrum of the unknown clear material in the through lumen showed similar absorption characteristics when comparing to zein like material.Zein is a component that is contained in some clot busting drugs.It was unable to be verified if the patient was given clot busting drug before or during the procedure.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.

Manufacturer Narrative

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: 9891599
• MDR Text Key: 195709323
• Report Number: 2015691-2020-11206
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 12TLW405F35
• Device Catalogue Number: 12TLW405F35
• Device Lot Number: 62431295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1