BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVAC PICC

    MDR report key: 41962 · Received September 23, 1996

    Report

    Report Number
    41962
    Event Type
    Injury
    Date Received
    September 23, 1996
    Date of Event
    September 9, 1996
    Report Date
    September 19, 1996
    Manufacturer
    VYGON CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO RN'S WERE INSERTING THE P.I.C. CATHETER VIA THE LEFT CEPHALIC VEIN. AT APPROX 35 CM, RESISTANCE WAS FELT. THE FIRST RN IMMEDIATELY STOPPED PASSING THE CATHETER. THE SECOND RN TOOK OVER THE PROCEDURE AND THE CATHETER "BOUNCED BACK" APPROX 1.5 CM AT THE TIME OF THE EXCHANGE. THE SECOND RN ATTEMPTED TO REMOVE THE CATHETER, INTRODUCER AND GUIDEWIRE SIMULTANEOUSLY. AT THAT POINT IT WAS APPARENT THAT THE CATHETER WAS SEVERED. TOURNIQUET WAS APPLIED TO ARM AT AXILLA AND PT TAKEN IMMEDIATELY TO THE ER. SHOULDER X-RAY DEMONSTRATED THE CATHETER AT THE AXILLA, AND A VASULAR SURGEON PERFORMED A CUTDOWN BUT THE CATHETER WAS NOT LOCATED. CHEST X-RAY THEN REVEALED THE CATHETER IN THE RIGHT LUNG BASE. RADIOLOGIST THEN REMOVED THE CATHETER UNDER FLUOROSCOPY VIA THE FEMORAL VENOUS ROUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVAC PICC PERIPHERALLY INSERTED CENTRAL CATHETER DQO VYGON CORP. 2190.10G 2268

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention