BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY CONE REMOVAL SYSTEM

    MDR report key: 1162748 · Received September 8, 2008

    Report

    Report Number
    2020394-2008-00250
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    GAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. ONLY THE DILATOR HUB AND THE SHEATH HUB WERE RETURNED FOR EVALUATION. THE MARKER BAND WAS NOT IN THE ORIGINAL SWAGED LOCATION AND THERE WAS AN IMPRINT OF THE ORIGINAL SWAGED LOCATION. THIS LENGTH FROM THE TIP OF THE SHEATH TO THE ORIGINAL SWAGED LOCATION WAS 6MM, BUT THE CURRENT MARKER BAND LOCATION FROM THE TIP WAS 32 CM. AN ATTEMPT WAS MADE TO MOVE THE MARKER BAND, BUT IT WAS UNSUCCESSFUL. IT IS UNKNOWN IF PATIENT OR PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT. THE INVESTIGATION CONFIRMED THE COMPLAINT. THE ROOT CAUSE IS UNKNOWN. PROPER DILATATION OF THE VESSEL MUST BE PERFORMED PRIOR TO INSERTION OF THE INTRODUCER CATHETER. THE CURRENT IFU STATES TO PRE-DILATE THE INSERTION SITE WITH A 12F DILATOR AND THEN ADVANCE THE INTRODUCER CATHETER TOGETHER WITH ITS TAPERED DILATOR OVER THE GUIDEWIRE TO THE TARGET AREA. IT ALSO STATES THE FOLLOWING. DO NOT USE EXCESSIVE FORCE WHEN MANIPULATING THE CONE. EXCESSIVE FORCE MAY DAMAGE THE CATHETER OR OTHER PARTS OF THE RECOVERY CONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL PROCEDURE OF AN IVC FILTER, THE MARKER BAND OF THE SHEATH CAME OFF AS THEY WERE PUTTING IT IN THE PATIENT. HE REMOVED THE SHEATH AND BROKEN RADIOPAQUE MARKER AND WAS ABLE TO USE ANOTHER TO REMOVE THE FILTER. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1