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

Model Number 12TLW805F35

Device Problems Complete Blockage (1094); Flushing Problem (1252); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

One fogarty thru-lumen embolectomy catheter was returned for evaluation.The through lumen was found to be occluded by an unknown clear material at the catheter tip.Balloon could not be inflated and back pressure was observed from the balloon inflation lumen.Balloon inflation lumen was found to be occluded by an unknown clear material at gate valve.Per ifu, "use of a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded".Both balloon and windings were intact.No other visible damage or inconsistency was observed from catheter body.The unknown material at both locations was removed and sent to chemistry for analysis.Balloon inflation testing was performed with lab syringe.Visual examination was performed under microscope at 10-200x 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 catheter was blocked was confirmed.A supplemental report will be sent with the chemistry investigation results.

Event Description

It was reported that the fogarty catheter could not be flushed before use.The catheter was blocked.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The ir spectrum of the unknown material isolated from inflation lumen showed similar absorption characteristics when comparing to zein like material.Using spectroscopy, the following elements detected were isolated from the thru lumen: carbon, sodium, silicon, iodine, calcium and chlorine.It is standard practice to flush all ports and lumens prior to insertion into the patient.If there is a partial occlusion that is not detected during setup and ultimately interferes with the function of the device, the catheter can be exchanged through an introducer with little impact to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The occlusion detected in the through lumen may be related to the contrast medium used by the hospital.It should be noted that the ifu indicates that a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• 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: 10407981
• MDR Text Key: 204052948
• Report Number: 2015691-2020-13131
• 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,Followup,Followup
• Report Date: 07/21/2020

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: 04/28/2022
• Device Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 62965331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 07/23/2020; 11/23/2020
• Supplement Dates FDA Received: 09/11/2020; 11/06/2020; 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1