BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1030570 · Received April 14, 2008

    Report

    Report Number
    1016427-2008-00113
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING; HOWEVER, AS OF TO DATE THE EVAL HAS NOT BEEN COMPLETED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE FILTER MARKER BANDS WERE NOT ALIGNED AFTER DEVICE WITHDRAWAL. THE REPORT RECEIVED INDICATED THAT AFTER SUCCESSFULLY USING THE ANGIOGUARD GUIDEWIRE, THE PHYSICIAN WITHDREW THE DEVICE SAFELY; HOWEVER, THE PHYSICIAN FELT THAT THE FOUR MARKERS OF THE FILTER BASKET DID NOT OVERLAP. THERE WERE NO ANOMALIES NOTED WITH THE MARKER BANDS; THE MARKERS WERE POSITIONED CORRECTLY; HOWEVER, THEY DID NOT OVERLAP AFTER THE CAPTURE SHEATH WAS ADVANCED TO CAPTURE THE FILTER. THE CAPTURE SHEATH HAD BEEN APPROPRIATELY ADVANCED UNTIL THE DISTAL MARKER ON THE SHEATH WAS ALIGNED WITH THE PROXIMAL MARKER ON THE GUIDEWIRE. FURTHER INFO INDICATED THAT DURING THE PROCEDURE, THERE WERE NO DIFFICULTIES ACHIEVING FILTER POSITION AND THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS NOT TORTUOUS, BUT INSTEAD PRESENTED MILD CALCIFICATION WITH 80% STENOSIS. THE TARGET LESION WAS SUCCESSFULLY TREATED WITHOUT ANY INJURY TO THE PT.

    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 70108503

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PRECISE STENT