BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY CONE REMOVAL SYSTEM

    MDR report key: 1070354 · Received June 30, 2008

    Report

    Report Number
    2020394-2008-00182
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    GAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AS THE SAMPLE WAS DISCARDED AT THE USER FACILITY. AND NO SAMPLE EVALUATION COULD BE PERFORMED. ALTHOUGH THE DEFINITIVE ROOT CAUSE IS UNKNOWN, IT APPEARS THAT PROCEDURAL ISSUES CONTRIBUTED TO OR MAY HAVE CAUSED THIS EVENT. IT IS IMPORTANT TO NOTE, THAT IT WAS REPORTED THAT THE GUIDEWIRE WAS IN PLACE (ACROSS THE FILTER) THROUGHOUT THE ENTIRE FILTER RETRIEVAL PROCEDURE, INCLUDING COLLAPSE AND REMOVAL INTO THE SHEATH. PER THE IFU, THE GUIDEWIRE IS TO BE WITHDRAWN INTO THE PUSHER SHAFT PRIOR TO FULL COLLAPSE OF THE FILTER. THE PURPOSE FOR THESE INSTRUCTIONS IS TO AVOID UNNECESSARY STRESSES THAT WOULD BE CAUSED BY THE ADDED INTERFERENCE OF THE GUIDEWIRE. AS THE GUIDEWIRE WAS NOT REMOVED, PRIOR TO COLLAPSE AND RETRACTION OF THE FILTER, IT IS POSSIBLE THAT INCREASED RESISTANCE WAS EXPERIENCED DURING THE FILTER RETRIEVAL. FURTHERMORE, THE GLIDEWIRE BRAND GUIDEWIRE IS A HYDROPHILIC COATED WIRE, WHICH ARE KNOWN TO CAUSE ADDED FRICTION IF NOT PROPERLY CONDITIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENA CAVA FILTER REMOVAL, THE HANDLE DETACHED FROM THE RETRIEVAL DEVICE. THE PHYSICIAN WAS IN THE PROCESS OF REMOVING THE FILTER, WITH IT ALREADY CAPTURED AND IN THE SHEATH. HE PULLED BACK THE SHAFT HANDLE TO REMOVE AND THE HANDLE DETACHED FROM THE SYSTEM. THE FILTER WAS ABOUT 20 CM FROM THE TIP OF THE SHEATH WHEN THIS HAPPENED. THE PHYSICIAN USED THE 10 FR. INTRODUCER SHEATH TO CAPTURE THE CATHETER AND REMOVE THE SYSTEM WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY CONE REMOVAL SYSTEM GAE BARD PERIPHERAL VASCULAR, INC. GFSB2096

    Patients

    Seq Age Sex Outcome Treatment
    1