BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 3856694 · Received May 19, 2014

    Report

    Report Number
    2032582-2014-00002
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    January 14, 2013
    Report Date
    April 18, 2014
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PROPERLY INVESTIGATE SINCE THE SAMPLE WAS NOT RETURNED. EVALUATION RESULTS: DHR REVIEW: THE QUALITY RECORDS FOR LOT 130660 000 ARE COMPLETE AND IN ORDER. THERE ARE NO NON-CONFORMANCE ASSOCIATED TO THIS LOT NUMBER. NO SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR THIS LOT. THE SAMPLE WAS NOT RETURNED FOR FURTHER INVESTIGATION. THE INVESTIGATION WAS BASED UPON THE HYPOTHESIS OF CATHETER DISCONNECTION AS CAUSE OF THE REPORTED PROBLEM. CATHETER DISCONNECTION TEST FOR LOT 130660 000 IS 28.75N SPEC >5N. BASED ON SIMILAR PORTS THAT HAVE BEEN RETURNED DUE TO SIMILAR COMPLAINTS, IT'S BEEN CONCLUDED THAT THE CATHETER CONNECTION WAS NOT CORRECTLY SECURED WITH THE LOCKING COLLAR AS DESCRIBED IN THE IFU. THE RISK OF CATHETER DISCONNECTION IS IDENTIFIED IN THE RISK ANALYSIS. THE REVIEW OF THE IFU SHOWS DETAILED/ADEQUATE INSTRUCTIONS FOR CONNECTION OF THE CATHETER TO THE PORT, SPECIFIC PICTURES IN THE IFU SHOW HOW TO CONNECT THE CATHETER AND SECURE WITH THE LOCKING COLLAR SYSTEM.

    Description of Event or Problem · 1

    EVENT DESC: PATIENT WAS TO HAVE LAB DRAWN AND CHEMOTHERAPY FROM HER PORT-A-CATH. IN LAB, UNABLE TO ASPIRATE. SOME EDEMA NOTED ABOVE PORT. NURSE ATTEMPTED TO FLUSH LINE; INCREASED EDEMA ABOVE PORT NOTED. PATIENT SENT TO INTERVENTIONAL RADIOLOGY. PORT FRAGMENT DISCOVERED IN PULMONARY ARTERY. THE FOREIGN BODY (FRAGMENT OF PORT-A-CATH, APPROXIMATELY 26CM OF CATHETER) WAS RETRIEVED FROM PATIENT'S PULMONARY ARTERY BY INTERVENTIONAL RADIOLOGY PROCEDURE PERFORMED UNDER MODERATE SEDATION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: LAB DRAW AND CHEMOTHERAPY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297816 XCELA CATHETER, INTRAVASCULAR, THERAPEUTIC LJT PFM MEDICAL, INC. 130660 000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other