BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST PICC

    MDR report key: 2214332 · Received August 5, 2011

    Report

    Report Number
    1625425-2011-00121
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 4, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PICC WAS LIFE LINE TO PT. THE CATHETER WAS REMOVED IN ITS ENTIRETY W/O ANY DISLODGEMENT TO THE HEART OR PULMONARY VASCULATURE. THE ADDED RADIATION ABSORBED DOSE (RAD) EXPOSURE WAS TWENTY MINS. AT TWENTY MINS, PHYSICIAN AND TEAM HAD A SMALL FRAGMENT DANGLING IN THE FEMORAL VEIN OUT OF REACH SURGICALLY. THE CONSEQUENCES OF THE PIECE EMBOLIZING TO THE HEART OR MORE DREADFUL TO THE PULMONARY VASCULATE COULD BE HUGE. THE TEAM WAS CLOSE TO REMOVING THE FRAGMENT VIA IR AND PHYSICIAN FELT IT WAS THE BEST AND SAFEST PROCEDURE WITH MORE RADS. INDEED THE DECISION PAID OFF AS THE FRAGMENT WAS RETRIEVED. TOTAL RAD WAS TWENTY-TWO MINS. L-CATH PICC ESSENTIALLY FELL APART AND REQUIRED INTERVENTIONAL RADIOLOGY TO REMOVE THE INTRA-ABDOMINAL INTRAVASCULAR PORTION OF THE CATHETER. PHYSICIAN HAD TO SURGICALLY REMOVE FRACTURED FRAGMENTS FROM THE LEG VEINS. PT'S OTHER THERAPIES IN USE ON PT: NOT KNOWN VEIN HAD CREATED A FIBRIN SHEATH AROUND THE CATHETER CAUSING IT TO BE STUCK WITHIN THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other