BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FFR

    MDR report key: 7893220 · Received September 19, 2018

    Report

    Report Number
    MW5079922
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 18, 2018
    Manufacturer
    ST. JUDE MEDICAL / ABBOTT LABORATORIES
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN FFR WIRE WAS LEFT IN THE PT AFTER FRACTIONAL FLOW RESERVE AND PCI PERFORMED. FFR WAS PERFORMED IN THE LAD. FFR OF LAD WAS NEGATIVE. MD THEN DECIDED TO MOVE FORWARD WITH PCI OF DIAGONAL. FFR WIRE WAS MOVED TO DIAG FOR PCI PORTION OF PROCEDURE. A BMW WIRE WAS INSERTED FOR PROCEDURE AS WELL. MD PRE-DILATED, STENTED AND POST-DILATED DIAG WITH FFR WIRE STILL PRESENT- NOT AN UNCOMMON PRACTICE. WHEN PCI WAS FINISHED, MD WENT TO TAKE FFR WIRE ALONG WITH BMW WIRE AND ALL OVER WIRES/BALLOONS OUT OF PT. THAT IS WHEN HE NOTICED THAT THE RADIOPAQUE PORTION OF THE FFR BROKE OFF AND STILL REMAINED IN THE PT'S DIAG. MD DECIDED THE RISK WOULD BE TOO HIGH TO REMOVE THE FFR WIRE AND DECIDED NOT TO TRY AND RETRIEVE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730453 FFR WIRE, GUIDE, CATHETER DQX ST. JUDE MEDICAL / ABBOTT LABORATORIES C12059 6349034

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention