BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2140915 · Received June 27, 2011

    Report

    Report Number
    1016427-2011-00064
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON-STERILE ANGIOGUARD WAS RECEIVED IN A PLASTIC BAG. A 1CM SECTION WAS OBSERVED TO BE UNRAVELED AT APPROXIMATELY 2CM FROM DISTAL TIP. NO OTHER ISSUES WERE FOUND. A 37CM SECTION OF THE DEPLOYMENT SHEATH WAS PEELED AWAY AT APPROXIMATELY 28 CM FROM DISTAL TIP. THE FILTER BASKET WAS WRONGLY LOADED INTO THE DELIVERY SHEATH SINCE IT WAS FURTHER THAN PER IFU. FILTER BASKET WAS TAKEN OUT FROM THE DELIVERY SHEATH IN ORDER TO VERIFY THAT PROXIMAL MARKER BAND AND STRUT MARKER BANDS WERE ON ITS POSITION, AFTER REMOVAL IT WAS OBSERVED THEY WERE ON ITS EXPECTED POSITION, AS WELL AS THE DISTAL MARKER BAND. FRESH BLOOD RESIDUES WERE OBSERVED IN THE DELIVERY SHEATH. THE UNIT WAS INSPECTED UNDER MICROSCOPE AND IT WAS OBSERVED THAT THE UNIT PRESENTED ANOTHER UNRAVELING CONDITION AT 3CM FROM DISTAL TIP. NOTE: LAKE REGION LOT NUMBER 01427379 WHICH IS CORDIS LOT NUMBER 70910509. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427379. THIS PACKAGING LOT CONTAINED 100 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON OCTOBER 15, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS: "DELIVERY SYSTEM- FAILURE TO CROSS" COULD NOT BE EVALUATED. THE ROOT CAUSE OF THIS FAILURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE PATIENT'S DIFFICULT ANATOMY AND PROCEDURAL MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANGIOGUARD DID NOT CROSS THE LESION AS THE BIFURCATION AND INTERNAL CAROTID ARTERY WERE PARTIALLY CALCIFIED AND TORTUROUS. ANALYSIS OF THE RETURNED WIRE REVEALED A 1CM SECTION OF THE COIL WIRE TO BE STRETCHED 2CM FROM DISTAL TIP, AND ANOTHER STRETCHED CONDITION WAS OBSERVED AT 3CM FROM THE DISTAL TIP. PER THE AFFILIATE, THE STRETCHED COILS OCCURRED WHEN THE PHYSICIAN TRIED TO RE-SHAPE THE TIP OF THE ANGIOGUARD IN ORDER TO TRY AND CROSS THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70910509

    Patients

    Seq Age Sex Outcome Treatment
    1