BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 3060344 · Received April 11, 2013

    Report

    Report Number
    1125782-2013-00010
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED DEVICE WAS RETURNED FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO RELATED EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS VISUALLY EXAMINED. THE COMPLIANT IS CONFIRMED. THE PIGTAIL OF THE CATHETER IS MISSING. THERE ARE MANY KINKS ALONG THE LENGTH OF THE CATHETER AND THE CENTER OF THE CATHETER IS SEVERELY TWISTED, DEFORMED, AND STRETCHED. THERE IS EVIDENCE OF EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE CATHETER. MERIT IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE FOR THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE CATHETER WAS PLACED TWO DAYS EARLIER DURING A PERICARDIOCENTESIS PROCEDURE. THE TIP NEAR THE PIGTAIL BROKE FREE UPON REMOVAL AND REMAINS IN THE PT. THE PHYSICIAN PERFORMED A CUT DOWN PROCEDURE IN AN ATTEMPT TO RETRIEVE THE CATHETER FRAGMENT BUT HE WAS UNABLE TO LOCATE THE FRAGMENT. THE PHYSICIAN DECIDED NOT TO MAKE ANY ADDITIONAL ATTEMPTS TO RETRIEVE THE CATHETER FRAGMENT. THE PT REMAINS IN THE HOSPITAL FOR ADDITIONAL DRAINAGE UNRELATED TO THIS EVENT. LOCATION OF THE CATHETER FRAGMENT IS NOT KNOWN. NO ADDITIONAL INFO HAS BEEN PROVIDED. NO ADDITIONAL HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154495 PERICARDIOCENTESIS KIT CATHETER, IRRIGATION GBX MERIT MEDICAL SYSTEMS, INC. T305634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention