BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1083781 · Received July 24, 2008

    Report

    Report Number
    1016427-2008-00203
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 4, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THEREAFTER THE PHYSICIAN TRIED TO DOCK THE FILTER AGAIN, BUT STRUT MARKER BANDS APPEARED ASYMMETRICALLY (GATHERED IN ONE SIDE) AND NOT PROPERLY CAPTURED. THEREFORE, THE 8F BRITETIP GUIDING CATHETER (GC)WAS USED TO REMOVE THE EMBOLIC PROTECTIVE DEVICE. EVENTUALLY, THE FILTER AND THE GC WERE REMOVED AS ONE UNIT AS THE FILTER WAS STUCK AT THE TIP OF THE GC. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT. THIS PROD HAS BEEN RETURNED FOR EVAL AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT COMPLETE. ADD'L INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT REC'D INDICATED THE MARKER BANDS OUT OF POSITION, FILTER DAMAGE AND WITHDRAWAL DIFFICULTY WITH DEVICE DURING USE. CAROTID ARTERY STENTING WAS BEING PERFORMED TO THE INTERNAL CAROTID ARTERY. THERE WAS MODERATE CALCIFICATION AND TORTUOSITY WITH 80% STENOSIS. NO ABNORMALITIES WERE NOTED DURING DEVICE INSPECTION AND PREPARATION. NO RESISTANCE WAS MET BETWEEN THE CAPTURE SHEATH AND THE EMBOLIC CAPTURE GUIDEWIRE. THE EMBOLIC PROTECTION DEVICE WAS DEPLOYED WITHOUT ANY REPORTED INCIDENT. HOWEVER, AT THE END OF THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN TRIED TO RETRIEVE THE FILTER USING THE CAPTURE SHEATH, BUT THE PROXIMAL PART OF THE FILTER WAS DETACHED FROM THE CORE WIRE AND THE FILTER COULD NOT BE DOCKED IN THE CAPTURE SHEATH. FURTHER INFO REVEALED THAT THE FILTER WAS DOCKED ONCE IN THE CAPTURE SHEATH, WHICH MEANS PROXIMAL MARKER BAND OF THE FILTER WAS ALIGNED WITH PROXIMAL MARKER OF THE CAPTURE SHEATH. HOWEVER, AFTER THE TORQUE DEVICE WAS ATTACHED, BOTH MARKER BANDS WERE SEPARATED. THE PHYSICIAN HAD NOT MOVED THE CAPTURE SHEATH OR THE FILTER GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70108516

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 8F BRITETIP GUIDING CATHETER / CORDIS