BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET ULTRA AVX

    MDR report key: 1141371 · Received August 22, 2008

    Report

    Report Number
    2183460-2008-00009
    Event Type
    Other
    Date Received
    August 22, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 22, 2008
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INSPECTION OF DEVICE: INSPECTED THE RETURNED AVX THROMBECTOMY SET AND NOTICED THE WINDOWS WERE SEVERELY DAMAGED AND EVERYTHING FROM THE PROXIMAL SADDLE TO THE TIP WERE SEPARATED FROM THE REST OF THE CATHETER. PREVIOUS INCIDENTS WITH THE SAME DAMAGE INDICATE THE GUIDEWIRE WAS RETRACTED INTO THE CATHETER AND THEN RETURNED BACK OUT THE WINDOWS OF THE CATHETER. WHEN THE CATHETER IS BEING REMOVED FROM THE PT, THE GUIDEWIRE CATCHES ON THE OUTSIDE OF THE SHEATH AND HEAVY RESISTANCE IS USUALLY INDICATED BY THE CUSTOMER SITE. THE PHYSICIAN WILL USE EXTREME FORCE PULLING ATTEMPTING TO WITHDRAW THE CATHETER AND THEN THE GUIDEWIRE WILL ACT LIKE A PRY BAR ON THE OUTSIDE OF THE SHEATH AND SPLIT THE CATHETER IN TWO PIECES. PAST INCIDENTS HAVE ALSO SHOWN THAT SOME SHEATH MANUFACTURERS ID ALMOST MATCHES THE AVX OD WHICH IN TURN WILL GIVE EVEN LESS AREA FOR THE CATHETER AND GUIDE WIRE TO ALL FIT INSIDE THE SHEATH AND BE REMOVED FROM THE BODY. CONCLUSION: THIS IS A PRODUCT FAILURE CONSISTING OF TIP SEPARATION CAUSED BY USER ERROR AND RESULTING IN ADDITIONAL INTERVENTION TO RETRIEVE THE CATHETER TIP. THE PRODUCT LABELING CLEARLY WARNS AGAINST RETRACTING THE GUIDE WIRE INTO THE CATHETER TIP AND REMOVING THE DEVICE AGAINST RESISTANCE AND RECOMMENDS REMOVAL OF THE CATHETER AND SHEATH AS A SINGLE UNIT; FOLLOWING THESE INSTRUCTIONS WOULD HAVE PREVENTED THIS EVENT. THE EVENT WAS REVIEWED WITH THE PHYSICIAN AND CATH LAB STAFF INCLUDING THE REMINDING THE USE OF THESE IFU INSTRUCTIONS.

    Description of Event or Problem · 1

    EVENT CONSISTS OF DURING AV DECLOT REMOVING AVX CATHETER MET RESISTANCE, PULLED, AND TIP WAS BROKEN. TIP WAS IN GRAFT AND REMOVED WITH FOGARTY. THIS RESOLVED EVENT WITH NO FURTHER SEQUELAE. THE CATHETER JAMMED ON WIRE WHICH HAD APPARENTLY EXITED THE INFLOW WINDOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET ULTRA AVX EMBOLECTOMY CATHETER DXE POSSIS MEDICAL, INC. 105039-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention