MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY CORKSCREW CATHETER; CATHETERS, THROMBECTOMY

Model Number 140806

Device Problems Break (1069); Material Rupture (1546)

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

Event Date 07/21/2023

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.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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, during use in patient with this fogarty corkscrew catheter, the latex covering the filaments was ripped.There was no allegation of patient injury.Patient demographics unable to be obtained.

Manufacturer Narrative

Updated: h3 (device evaluated by manufacturer), h6 (component code, device code, type of investigation, investigation findings, investigation conclusions).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.As received, the latex membrane was torn at the distal membrane bonding site and exposing the spiral cable and spring tip.Spiral cable was exposed through a tear of approximately 0.3" 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 ifu "exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation" and "to minimize the risk of vessel or membrane damage, do not exceed the maximum recommended pull force".Further investigation was performed by the engineers in the manufacturing site.Based on the available information it cannot be confirmed that this complaint is associated to a manufacturing or design defect.Additionally, 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 a 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 CORKSCREW CATHETER
• Type of Device: CATHETERS, THROMBECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18422825
• MDR Text Key: 331669436
• Report Number: 2015691-2023-18833
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Model Number: 140806
• 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: 12/30/2023
• Supplement Dates Manufacturer Received: 12/30/2023; 02/21/2024
• Supplement Dates FDA Received: 01/25/2024; 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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