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

Model Number 140806

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this fogarty corkscrew catheter, the handle activation button did not work.There was no allegation of patient injury.The device was received for evaluation.Spiral cable was found exposed through a tear in the latex membrane.Patient demographic information unable to be obtained.

Manufacturer Narrative

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.One fogarty corkscrew catheter was received by our product evaluation laboratory for a full examination.Spiral cable was exposed through a tear in the latex membrane.Edges of the torn region appeared to match up.There was no visible damage observed to the catheter body.It was able to move the thumb slide on the handle forwards and backwards and the membrane extended and contracted respectively.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

Further investigation was completed by the engineers in the manufacturing site.Customer report of "handle activation button did not work" was unable to be confirmed.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.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.

• 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: 18709803
• MDR Text Key: 335444281
• Report Number: 2015691-2024-01026
• 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
• 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
• Device Lot Number: 64676803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2022
• 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