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

Model Number 140808

Device Problem Break (1069)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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

As reported, before use in patient with this fogarty embolectomy catheter, the latex covering the filaments was ripped.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions).Added: d4 (expiration date), h4 (device manufacturing date) the fogarty catheter was sent to our product evaluation laboratory for a full evaluation.Customer report of "latex covering the filaments was ripped" was confirmed.Spiral cable was exposed through a tear of approximately 0.2" in length in the latex membrane.Edges of the torn region appeared to match up.There was no visible damage observed to the catheter body.Both the core wire and the thumb slide on the handle were functional.Per instructions for use: "to minimize the risk of vessel or membrane damage, do not exceed the maximum recommended pull force" and "exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation".Further investigation was performed by the engineers in the manufacturing site.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.As part of the manufacturing process, a visual inspection is performed to all catheters for general appearance, length of the tube, diameter of the bonding and spiral coil verification in closed position and an inspection of the functionality of the handler is performed activating it 3 consecutive times to verify the behavior of the coils, spiral and latex membrane integrity.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18391469
• MDR Text Key: 331293406
• Report Number: 2015691-2023-18752
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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 Model Number: 140808
• Device Lot Number: 64493843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2022
• 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