BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGEN REINFORNCED DUAL LUMEN CATHETER

    MDR report key: 8415478 · Received March 13, 2019

    Report

    Report Number
    1646848-2019-00002
    Event Type
    Injury
    Date Received
    March 13, 2019
    Report Date
    January 10, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAD BEEN NO REPORTS OF ATRIAL PERFORATION ON THE REINFORCED DUAL LUMEN CATHETER, ALL SIZES AS OF THE DATE OF THIS REPORT OUT OF 1,106 CATHETERS PLACED. THE PCT KIT IFU FOR POSITIONING OF THE CATHETER STATES THE FOLLOWING REGARDING POSITIONING: "CONTINUE ADVANCING THE GUIDEWIRE TO THE MID-RIGHT ATRIUM. NOTE: THE GUIDEWIRE IS MARKED AT 10, 20, AND 30 CM DISTANCES FROM THE J-TIP. USE ECHO, RADIOGRAPHY OR OTHER MEANS TO CONFIRM POSITION." THE CATHETER IFU STATES THE FOLLOWING REGARDING POSITIONING: "USE X-RAY OR ECHO TO VERIFY THAT THE CATHETER TIP IS POSITIONED IN THE NID RIGHT ATRIUM BEFORE USE. INCORRECT INSERTION MAY RESULT IN PUNCTURE OF THE RIGHT ATRIUM OR VEIN." ON SEPTEMBER 12, 2014, DR. (B)(6) REPORTED THAT HE BELIEVED THE EVENT TO BE A RESULT OF "PILOT ERROR".

    Description of Event or Problem · 1

    (B)(6) HOSPITAL REPORTED THAT THE EXTENDED SURGEON GROUP HAD TWO ATRIAL PERFORATIONS WITH THE NEW WIRE-REINFORCED ORIGEN CATHETER DURING THE PAST TWO WEEKS ((B)(6) 2014 - (B)(6) 2014).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209629 ORIGEN REINFORNCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV13F

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R