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

Model Number 140806

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported, that after the latex membrane of the 140806 fogarty corkscrew catheter was expanded into a helical configuration.It could not be returned to the extended state during use.Additional incision was required to remove the catheter.There were no patient complications reported.

Manufacturer Narrative

The product is expected to be returned for analysis, but has not yet been received.Upon the return of the product, a supplemental report will be sent with the investigation results.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.The lot number was not provided.Therefore, a review of the manufacturing records could not be 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.

Manufacturer Narrative

A supplemental mdr is being submitted due to the product evaluation findings and engineering evaluation.Sections g6, h2 and h6 for component code, type of investigation findings, investigation findings, and investigation conclusions have been updated.Our product evaluation lab received one model 140806 adherent clot catheter.There was no visible damage observed in the core wire, catheter body, latex membrane, and the spring.It was able to move the thumb slide on the handle forwards and backwards and the membrane extended and contracted respectively without difficulty.The customer report that the latex membrane could not be returned to the extended state was unable to be confirmed during evaluation.An engineering evaluation has been completed and no device problem was detected.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.

• 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: 17362418
• MDR Text Key: 319739242
• Report Number: 2015691-2023-14696
• 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): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 140806
• Device Catalogue Number: 140806
• Device Lot Number: 64743257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2022
• 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 Outcome(s): Required Intervention