BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARGON L-CATH PICC

    MDR report key: 3592975 · Received November 13, 2013

    Report

    Report Number
    1625425-2013-00021
    Event Type
    Other
    Date Received
    November 13, 2013
    Report Date
    November 13, 2013
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    LJS
    PMA / PMN Number
    K920755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE CONSISTED ON JUST A SMALL PORTION OF THE CATHETER TUBING (7.5CM LONG) AND IT WAS RECEIVED IN A PLASTIC CONTAINER. THE CATHETER HUB WAS NOT RETURNED WITHIN THE SAMPLE; THEREFORE, IT IS POSSIBLE THAT THE PORTION OF TUBING RECEIVED CORRESPONDS TO THE PORTION THAT REMAINED INSIDE OF THE PT WHEN THE CATHETER BROKE. THE EXAMINATION OF THE SAMPLE UNDER DIFFERENT MAGNIFICATIONS REVEALED "UNEVEN JAGGED EDGE" AT BOTH EDGES OF THE PORTION OF TUBING. THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND DOCUMENTED PROCEDURES. COMPARING THE PROBLEM DESCRIPTION AND THE RESULTS OF SAMPLE EVALUATION TO THE RISK MANAGEMENT DOCUMENTATION AND THE INSTRUCTIONS FOR USE, THE RESISTANCE DURING CATHETER REMOVAL MOST LIKELY WAS DUE TO RAPID REMOVAL OF THE CATHETER CAUSING VASOSPASM OR PRESSURE ON THE INSERTION SITE PRIOR TO REMOVAL LEADING TO VASOCONSTRICTION. THE BREAKAGE ISSUE WAS DUE TO EXCESSIVE STRESS APPLIED TO THE CATHETER; THE TENSILE STRENGTH OF THE CATHETER WAS EXCEEDED.

    Description of Event or Problem · 1

    PICC LINE BREAKAGE DURING REMOVAL. LINE REMOVED. FURTHER INFO: ORDER FOR REMOVAL OF PICC LINE. ON FIRST ATTEMPT, LINE EASILY SLID OUT ABOUT 19CM (30CM TOTAL IN PT) AND THEN RESISTANCE WAS MET. SITE WAS REDRESSED AND WARM COMPRESSES WERE APPLIED TO RLE AND PICC INSERTION SITE. ONE HOUR LATER, SECOND ATTEMPT WAS MADE TO REMOVE PICC. ANOTHER NURSE WAS PRESENT HELPING WITH POSITIONING AND HOLDING EXTREMITY WAS ABLE TO FURTHER REMOVE PICC ABOUT 5CM MORE AND INTERMITTENT RESISTANCE WAS MET. SECOND NURSE LEFT AFTER ABOUT 20 MINUTES AND FIRST NURSE CONTINUED TO ATTEMPT REMOVAL WITH LIGHT PRESSURE. CATHETER SNAPPED OUTSIDE INSERTION SITE; NURSE WAS ABLE TO GRAB LOOSE END OF STILL INSERTED PART OF CATHETER AND CALLED FOR HELP. ANOTHER NURSE CAME AND APPLIED MORE WARM COMPRESSES, TOURNIQUET TO EXTREMITY, MANU PRESSURE ON VEIN AND SECURED LOOSE END WITH TEGADERM. MD PAGED TO BESIDE. WITHIN 2 MINUTES LOOSE END WAS NO LONGER VISIBLE OUTSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589673 ARGON L-CATH PICC L-CATH LJS ARGON MEDICAL DEVICES INC. NA 11032171

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R