BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3072462 · Received April 23, 2013

    Report

    Report Number
    1016427-2013-00050
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS ORIGINALLY REPORTED AN ANGIOGUARD DID NOT CROSS THE INTERNAL CAROTID ARTERY LESION. THE VESSEL WAS DESCRIBED AS CALCIFIED AND TORTUOUS WITH A 90% STENOSIS. IT IS UNKNOWN IF THE PRODUCT LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING. IT IS UNKNOWN IF THE DEVICE WAS PROPERLY PREPPED. IT IS UNKNOWN IF THERE WAS ANY INJURY TO THE PATIENT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING AND THE ANALYSIS REVEALED THAT A 1MM SECTION OF THE COIL WIRE WAS UNRAVELED AT APPROXIMATELY .5CM FROM TIP. ONE NON-STERILE ANGIOGUARD RX WAS RECEIVED IN A PLASTIC BAG. IT WAS OBSERVED THAT THE GUIDEWIRE PRESENTED A BENT AT APPROXIMATELY 2CM FROM TIP. THE DEPLOYMENT SHEATH PRESENTED A KINKING CONDITION AT APPROXIMATELY 6CM FROM ITS TIP. THE BENDING CONDITION FOUND IN THE COIL AND THE DEPLOYMENT SHEATH COULD BE RELATED TO THE SHIPPING AND/OR STORAGE OF THE SAMPLE. THE UNIT WAS INSPECTED AND IT WAS OBSERVED THAT A 1MM SECTION OF THE COIL WIRE WAS UNRAVELED AT APPROXIMATELY .5CM FROM TIP. THE FILTER BASKET AND MEMBRANE WERE INSPECTED UNDER MICROSCOPE AND NO EVIDENCE OF DAMAGE WAS OBSERVED. LOT NUMBER WAS NOT PROVIDED; THEREFORE, DHR REVIEW IS NOT APPLICABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS: 'DELIVERY SYSTEM- FAILURE TO CROSS' COULD NOT BE EVALUATED DUE TO THE NATURE OF THE COMPLAINT. 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 BENDING/ UNRAVELING AND KINKING CONDITIONS FOUND IN THE COIL AND THE DEPLOYMENT SHEATH RESPECTIVELY COULD BE RELATED TO THE SHIPPING AND/OR STORAGE OF THE SAMPLE. 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 FAILURE TO CROSS WHICH MAY TO THE REPORTED UNRAVELING OF THE DISTAL WIRE. THE EVENT MAY HAVE ALSO BEEN CAUSED DURING SHIPPING, STORAGE, OR HANDLING OF THE RETURNED UNIT. WITH THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    AS ORIGINALLY REPORTED, THE ANGIOGUARD RX DID NOT CROSS ICA LESION. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE VESSEL WAS DESCRIBED AS CALCIFIED, TORTUOUS, RATE OF STENOSIS OVER 90%. IT IS UNKNOWN IF THE PRODUCT LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING. IT IS UNKNOWN IF THE DEVICE WAS PROPERLY PREPPED. AN EMBOSHIELD EPD WAS USED TO HELP COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS ANY INJURY TO THE PATIENT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING AND THE ANALYSIS REVEALED THAT A 1MM SECTION OF THE COIL WIRE WAS UNRAVELED AT APPROXIMATELY .5CM FROM TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175114 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1