MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ADHERENT CLOT CATHETER; FOGARTY CORKSCREW CATHETER

Model Number 140806

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

It was reported that during use, the membrane from the model 140806 fogarty corkscrew catheter, lot 67180475, got torn at the part where the wire was exposed.According to the sales rep, the membrane appeared to be attached above and below the site where the wire was exposed.There were no patient complications reported.

Manufacturer Narrative

The product was recently returned for analysis and a supplemental report will be sent with the investigation results.A device history record review has been initiated to demonstrate whether the device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Our product evaluation lab received one model number 140806 adherent clot catheter without any attached components.The latex membrane was torn around proximal bonding site and exposing the spiral cable and spring.The latex membrane was inverted.It was able to move the thumb slide on the handle forwards and backwards smoothly, but the spiral cable became distorted when the handle was pulled back to the contracted position.After cutting the proximal and distal latex membrane at the bonding sites, it was returned to the original position.A closer examination found that torn edges appeared the same shape.The catheter body appeared to be in good condition without any damages or defects.The handle was opened, and no damage or abnormality was found.A device history record review was completed and documented that the device met all specifications upon distribution.Additional evaluation completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that the membrane of the corkscrew catheter was completely torn off at the part where the wire was exposed.The potential for vessel injury is not remote.The product evaluation lab found the spiral cable was distorted and latex was inverted but the edges appeared the same shape.Additional evaluation completed.

• Brand Name: FOGARTY ADHERENT CLOT CATHETER
• Type of Device: FOGARTY CORKSCREW CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 15839464
• MDR Text Key: 306447473
• Report Number: 2015691-2022-09393
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901625
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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: 04/28/2024
• Device Model Number: 140806
• Device Catalogue Number: 140806
• Device Lot Number: 64180475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 51 KG