BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1880583 · Received October 22, 2010

    Report

    Report Number
    1016427-2010-00128
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN REMOVING THE ANGIOGUARD RX ECGW 6MM X 180CM-EXTRA SUPPORT DEVICE FROM THE DISPENSER WHILE PULLING THE TORQUE DEVICE, THE WIRE WOULD NOT ADVANCE THROUGH THE BLACK DEPLOYMENT SHEATH AND IT FORMED A LOOP AT THE BASE OF THE BLACK SHEATH. THE LOOP WOULDN'T EXPAND THEN. THE LOOP IT WOULD NOT STRAIGHTEN OUT AND COULD NOT BE PULLED THROUGH THE DISPENSER. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOT WHEN REMOVED FROM THE PACKAGING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. INITIALLY NO PRODUCT WAS RETURNED FOR ANALYSIS; HOWEVER, FOUR PHOTOS WERE RECEIVED WHICH SHOW AN ANGIOGUARD DEVICE COILED, WITH THE TORQUE DEVICE ATTACHED TO PROXIMAL SECTION OF THE DELIVERY WIRE, THE FILTER BASKET DEPLOYED, AND A LOOP AT THE BASE OF THE BLACK DEPLOYMENT SHEATH FORMED BY THE DEPLOYMENT SHEATH (UNZIPPED CONDITION WAS NOTED). THE PRODUCT HAS SINCE BEEN RETURNED. ONE NON STERILE ANGIOGUARD WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE TORQUE DEVICE WAS ATTACHED TO THE PROXIMAL SECTION OF THE DELIVERY WIRE. THE DELIVERY WIRE PRESENTED KINKS AT 6.5CM AND 7.5CM FROM PROXIMAL END. AN UNZIPPED SECTION ON THE DEPLOYMENT SHEATH WAS NOTED FROM 117.8CM TO 121.5CM FROM THE GREEN HUB. THE DEPLOYMENT SHEATH DISTAL END PRESENTED A SPLIT CONDITION. THE TIP COIL PRESENTED A KINK NEAR TO THE BULLET COIL. THE FILTER BASKET WAS RECEIVED DEPLOYED FROM DEPLOYMENT SHEATH. THE COIL DISPENSER INVOLVED WAS NOT RETURNED FOR ANALYSIS. THE FILTER BASKET WAS INSPECTED UNDER A MICROSCOPE AND THE FILTER BASKET MEMBRANE WAS FOUND DAMAGED. THE KINK CONDITION FOUND IN THE VISUAL ANALYSIS OVER THE COIL TIP WAS OBSERVED UNDER THE MICROSCOPE AND WAS CONFIRMED THIS DAMAGE. BECAUSE THE DEVICE WAS ULTIMATELY REMOVED FROM THE DISPENSER, THE REPORTED DIFFICULTY REMOVING FROM THE DISPENSER AND ITS IMPACT ON THE RESULTING CONDITION OF THE DEVICE COULD NOT BE EVALUATED. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE THE CONDITION OF THE DEPLOYMENT SHEATH. THE TIMING OF THE DAMAGE TO THE ANGIOGUARD FILTER BASKET NOTED ON THE RETURNED PRODUCT CANNOT BE DETERMINED. BECAUSE THE DEVICE WAS RECEIVED WITH THE FILTER BASKET DEPLOYED, IT IS POSSIBLE THAT THE FILTER DAMAGE OCCURRED DUE TO POST PROCEDURAL HANDLING/PACKING/RETURN. NO CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, PROCEDURAL HANDLING FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PREPARATION OF THE ANGIOGUARD RX ECGW 6MM X 180CM-EXTRA SUPPORT DEVICE, WHILE PULLING THE TORQUE DEVICE, THE WIRE WOULD NOT ADVANCE THROUGH THE BLACK DEPLOYMENT SHEATH AND IT FORMED A LOOP AT THE BASE OF THE BLACK SHEATH. THE LOOP WOULDN'T EXPAND THEN. THE EVENT OCCURRED WHEN THE DEVICE WAS BEING REMOVED FROM THE DISPENSER. THE LOOP IT WOULD NOT STRAIGHTEN OUT AND COULD NOT BE PULLED THROUGH THE DISPENSER. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOT WHEN REMOVED FROM THE PACKAGING. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. THE PRODUCT ANALYSIS WAS COMPLETED AND STATES THAT THE FILTER MEMBRANE WAS DAMAGED WHEN THE PRODUCT WAS LOOKED AT UNDER MICROSCOPE.

    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 70210532

    Patients

    Seq Age Sex Outcome Treatment
    1