BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ADHERENT CLOT CATHETER

    MDR report key: 17362418 · Received July 20, 2023

    Report

    Report Number
    2015691-2023-14696
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    July 3, 2023
    Report Date
    August 22, 2023
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    K901625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37923 FOGARTY ADHERENT CLOT CATHETER FOGARTY CORKSCREW CATHETER DXE EDWARDS LIFESCIENCES, PR 140806 64743257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention