BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3648067 · Received February 26, 2014

    Report

    Report Number
    1016427-2014-00025
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 16, 2014
    Report Date
    February 5, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING THE STUDY INDEX PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY RETRIEVING THE 7 MM. ANGIOGUARD FILTER INTO THE CAPTURE SHEATH. A PRECISE 10 X 30 STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (LICA) TARGET LESION. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, OR ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE ANGIOGUARD WAS REMOVED SUCCESSFULLY. THERE WAS NO DEBRIS NOTED IN THE FILTER BASKET. THE PATIENT WAS DISCHARGED THREE (3) DAYS AFTER THE INDEX PROCEDURE. NO TARGET LESION INFORMATION WAS AVAILABLE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. LR FILE # (B)(4), LR PACKAGING L/N 10316737, CORDIS L/N 70913451. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10316737. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON OCTOBER 7, 2013. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. WITH THE INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING THE STUDY INDEX PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY RETRIEVING THE 7 MM. ANGIOGUARD FILTER INTO THE CAPTURE SHEATH. A PRECISE 10 X 30 STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (LICA) TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, OR ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE ANGIOGUARD WAS REMOVED SUCCESSFULLY. THERE WAS NO DEBRIS NOTED IN THE FILTER BASKET. THE PATIENT WAS DISCHARGED THREE (3) DAYS AFTER THE INDEX PROCEDURE. NO TARGET LESION INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118210 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70913451

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR PRECISE 10 X 30 STENT