BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1202196 · Received October 16, 2008

    Report

    Report Number
    1016427-2008-00266
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT# 1016427-2008-00267.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN INTERVENTIONAL PROCEDURE FOR CAROTID STENT PLACEMENT, THE DISTAL FLOPPY OF THE ANGIOGUARD 6 MM-EMBOLIC PROTECTION DEVICE BECAME FRAYED WHILE ATTEMPTING TO CROSS THE TARGET LESION AND COULD NOT MAINTAIN ITS SHAPE. THE PHYSICIAN USED A SECOND DEVICE AND IT BECAME FRAYED ALSO. A THIRD DEVICE WAS USED AND THE PHYSICIAN WAS ABLE TO CROSS THE TARGET LESION. THE CAROTID ARTERY TARGET LESION (SIDE NOT PROVIDED) WAS REPORTED TO BE: HEAVILY CALCIFIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFO WAS AVAILABLE. THERE WAS NO REPORTED PT INJURY.

    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 70508512

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK