BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 2181934 · Received October 24, 2007

    Report

    Report Number
    2020394-2007-00293
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Date of Event
    September 24, 2007
    Report Date
    September 24, 2007
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. UPON INSPECTION OF THE RETURNED SAMPLE, THE DISTAL MARKER BAND WAS MISSING FROM THE INTRODUCER SHEATH. THE MARKER BAND WAS RETURNED SEPARATE, IN A SPECIMEN CUP. THE SHEATH APPEARED TO HAVE 2 KINKS AND ONE BEND. THE BEND WAS JUST PROXIMAL OF THE PROXIMAL MARKER BAND. THE DISTAL TIP OF THE INTRODUCER, SHEATH BACK TO THE PROXIMAL MARKER BAND, APPEARED VERY WAVY. ALSO OBSERVED WAS THE IMPRESSION ON THE INTRODUCER SHEATH, WHERE THE DISTAL MARKER BAND HAD ORIGINALLY BEEN PLACED. THE MEASUREMENT OF THE DISTAL EDGE OF THE PROXIMAL GOLD BAND WAS OUT OF SPECIFICATION; THIS MAY HAVE BEEN DUE TO THE WAVY SECTION OF THE DISTAL TIP AREA OF THE INTRODUCER SHEATH. ALL OTHER SHEATH MEASUREMENTS WERE WITHIN SPECIFICATION. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR THE DISTAL MARKER BAND DETACHED FROM THE COMPONENT, ROOT CAUSE UNKNOWN. IT IS POSSIBLE THAT PATIENT (SCAR TISSUE) AND/OR PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT. USER FACILITY MW REPORT (B)(4) WAS FORWARDED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A RIGHT FEMORAL ACCESS, THE DOCTOR HAD A HARD TIME GAINING ACCESS WITH A NEEDLE DUE TO THE PATIENT'S SCAR TISSUE IN THAT AREA, SO HE HAD TO USE A MICRO-PUNCTURE SET. DURING THE DEPLOYMENT, IT WAS DISCOVERED THAT THE DISTAL MARKER WAS NOT ON THE SHEATH. POST PLACEMENT, USING FLUOROSCOPY, THE MARKER WAS FOUND IN THE PATIENT'S SOFT TISSUE OF THE GROIN. THE DOCTOR RETRIEVED THE MARKER WITH FORCEPS THROUGH THE ORIGINAL INSERTION SITE. THE FILTER DEPLOYED FINE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR