BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD SNARE RETRIEVAL KIT

    MDR report key: 6964903 · Received October 20, 2017

    Report

    Report Number
    2135342-2017-00005
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Report Date
    September 21, 2017
    Manufacturer
    HERAEUS MEDICAL COMPONENTS, LLC
    Product Code
    MMX
    PMA / PMN Number
    K152560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED, THEREFORE NO DEVICE EVALUATION COULD BE PERFORMED. REVIEW OF MANUFACTURING AND STERILIZATION RECORDS SHOWED THE DEVICE MET SPECIFICATIONS. PER DISCUSSION WITH THE CLINICAL SPECIALIST, THE SNARE PROPERLY CAPTURED THE FILTER RETRIEVAL HOOK AND MAINTAINED CONTROL OF THE FILTER. DUE TO THE FILTER NOT BEING ENTIRELY PULLED INTO THE RETRIEVAL SHEATH, ONE OF THE CAUDAL ANCHORS REMAINED OUTSIDE THE SHEATH AND BECAME LODGED IN THE TISSUE SURROUNDING THE JUGULAR ACCESS SITE. THE IFU STATES, " ONCE THE FILTER IS FULLY COLLAPSED INSIDE THE RETRIEVAL SHEATH, RETRACT THE FILTER, SNARE, AND RETRIEVAL SHEATH AS ONE UNIT OUT THROUGH THE 11F ACCESS SHEATH." THERE IS NO INDICATION THAT THE SNARE RETRIEVAL DEVICE MALFUNCTIONED. IT APPEARS THAT THE DIRECTIONS, AS STATED IN THE IFU, WERE NOT COMPLETELY FOLLOWED. THIS EVENT OCCURRED IN (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A JUGULAR VENA CAVA FILTER RETRIEVAL PROCEDURE, ALLEGEDLY, THE FILTER COULD NOT BE PULLED INTO THE SHEATH ENTIRELY. A CAUDEL ANCHOR WAS LEFT OUTSIDE OF THE SHEATH AND GOT STUCK ON A MUSCLE UPON REMOVAL. A SMALL INCISION WAS MADE TO WIDEN THE ACCESS SITE, AND THE FILTER WAS RETRIEVED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744584 BARD SNARE RETRIEVAL KIT SNARE MMX HERAEUS MEDICAL COMPONENTS, LLC SRK35 MO44458

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR