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 11/28/2023

Event Type  malfunction  

Event Description

As reported, during use with this fogarty corkscrew catheter, the latex covering the filaments was ripped.There is no allegation of patient injury.Patient demographics unable to be obtained.

Manufacturer Narrative

The fogarty corkscrew catheter was received in the laboratory for a full evaluation.As per product evaluation findings, the latex membrane was torn around proximal membrane bonding site and exposing the spiral cable and spring body.Edges of the torn region appeared to match up.The latex membrane was inverted.Per edwards 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.The cable wire under the latex was bent.No visible damage was observed from catheter body.Both the core wire and the thumb slide on the handle were functional.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 with these three fogarty corkscrew catheters used in the same patient (medwatch #41616 and medwatch #42319 and medwatch #44106), the latex covering the filaments was ripped.There is no allegation of patient injury.The devices were available for evaluation.

Manufacturer Narrative

Updated: b5 (describe event or problem), h6 (component code, impact code, type of investigation, investigation findings, investigation conclusions).This catheter was sent to our product evaluation laboratory for full evaluation.As per further follow up with the site it was confirmed that the three of them were used in the same patient, same procedure.Three fogarty catheters were received instead of the two units originally reported.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/design defect.As part of the manufacturing process, a 100% visual inspection is performed to the catheter for general appearance, length of the tube, diameter of the bonding and spiral coil verification in closed position and a 100% 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
• 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: 18856809
• MDR Text Key: 337293920
• Report Number: 2015691-2024-01677
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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: 140808
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/05/2024
• 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