BEUDAMED
    FDA Adverse Event Other Summary report: N

    SECURACATH

    MDR report key: 3693330 · Received March 11, 2014

    Report

    Report Number
    3007795799-2014-00012
    Event Type
    Other
    Date Received
    March 11, 2014
    Date of Event
    November 15, 2013
    Report Date
    March 3, 2014
    Manufacturer
    INTERRAD MEDICAL INC
    Product Code
    OKC
    PMA / PMN Number
    K120935
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVICE MALFUNCTION NOR HARM TO THE PATIENT. TISSUE GROWTH AROUND THE ANCHOR IS NORMAL AND REMOVAL OF THE ANCHOR UNDER THESE CONDITION IS DESCRIBED IN THE IFU. A RAPID DELIBERATE TUG OF THE ANCHOR IS REQUIRED TO REMOVE THE ANCHOR FROM THE SUBCUTANEOUS SPACE IF TISSUE GROWTH IS PRESENT. THIS GENERALLY RESULTS IN LITTLE OR NO DISCOMFORT FROM THE PATIENT AND IS PREFERRED TO THE GENTLE TENTATIVE ANCHOR REMOVAL.

    Description of Event or Problem · 1

    THE RISK MANAGER AT (B)(6) REPORTED THAT THERE WERE REPORTS OF DIFFICULTY IN REMOVING THE ANCHOR FROM PATIENT'S WITH TISSUE SCAR ADHESION AROUND THE DEVICE. THE NURSE(S) WERE TRYING TO REMOVE THE ANCHOR GENTLY TO AVOID HURTING THE PATIENT RESULTING IN DIFFICULTY REMOVING THE ANCHOR AND DISCOMFORT FOR THE PATIENT. THERE WERE NO DEVICE MALFUNCTION AN NO ADVERSE EVENT. THIS INCIDENT OCCURRED DURING THE EARLY IMPLEMENTATION PHASE OF THE DEVICE, WHEN MANY CLINICIANS WERE JUST BEGINNING TO USE THE DEVICE. THE COMPANY HAS FOUND THE REMOVAL PROCESS BECOMES EASIER ONCE EXPERIENCE HAS BEEN OBTAINED. ON SOME PATIENTS, ESPECIALLY WITH LONGER DWELL TIMES, THE ANCHORS BECOME MORE EMBEDDED IN THE TISSUE. FOR THESE CASES, THE ANCHOR NEEDS TO BE PULLED OUT USING A SWIFT, DELIBERATE TUG. THE SMALL, BLUNT ANCHORS STRAIGHTEN WHEN PULLED OUT WITHOUT DAMAGING THE SKIN. THE REMOVAL OF SECURACATH, WHEN DONE CORRECTLY, CAN BE EQUATED TO THE REMOVAL OF A HUBER NEEDLE FROM AN IMPLANTED PORT IN THAT SOME PATIENTS MAY EXPERIENCE MOMENTARY PAIN IF ANY UPON REMOVAL WHICH QUICKLY SUBSIDES UPON COMPLETION OF THE REMOVAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145377 SECURACATH SECUREMENT FOR INTRAVASCULAR DEVICES OKC INTERRAD MEDICAL INC SCR-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1