BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2221433 · Received August 24, 2011

    Report

    Report Number
    1016427-2011-00081
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 1, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT WAS ADMITTED ASYMPTOMATIC WITH AN 80% STENOSIS IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. AN ANGIOGUARD RX EMBOLIC PROTECTION GUIDEWIRE WAS SUCCESSFULLY DEPLOYED AND A 9 X 40MM PRECISE PRO RX WAS DEPLOYED WITH NO MALFUNCTION OR ASSOCIATE MAJOR ADVERSE EVENT. DIFFICULTY WAS ENCOUNTERED WHILE TRYING TO CAPTURE THE FILTER BASKET INTO THE CAPTURE SHEATH. SEVERAL ATTEMPTS WERE MADE BEFORE THE RETRIEVAL SHEATH WAS FIRMLY PUSHED ONTO BASKET. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED AND THERE WAS NO ADVERSE EVENT TO THE PATIENT. THE PATIENT WAS DISCHARGED TWO DAYS LATER WITH NO MAJOR ADVERSE EVENT. (B)(4). 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. 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 EVENT. HOWEVER, PROCEDURAL FACTORS AND/OR DEVICE INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE DEVICE DID NOT PASS THROUGH ANY ACUTE BENDS. THERE WAS NO DIFFICULTY OR RESISTANCE NOTED WHILE CROSSING THE LESION WITH THE DEVICE. THE FILTER BASKET FULLY EXPANDED WITH GOOD WALL APPOSITION. THE LESION WAS POST-DILATED AFTER STENT IMPLANTATION WITH A 5 X 20MM BALLOON AT 12 ATM. THE STENOSIS AFTER POST-DILATION WAS 20%. THERE WAS NO DIFFICULTY ADVANCING THE CAPTURE SHEATH TO THE LESION. DURING FILTER RETRIEVAL, THE RETRIEVAL SHEATH WAS ADVANCED WHILE THE FILTER WIRE WAS FIXED. THERE WAS NO FILTER BASKET DEFORMATION. THERE WAS NO FORCE REQUIRED FOR WITHDRAWAL OF THE FILTER PRIOR TO THE MARKER BAND DISLODGEMENT OR FILTER DEFORMATION. DURING THE PROCEDURE, THE FILTER WAS DISTAL ENOUGH FROM THE LESION TO PREVENT ANY INTERACTION FROM THE BALLOONS/SDS USED. THERE WAS NO INTERACTION BETWEEN THE FILTER BASKET PROXIMAL MARKER BAND AND THE DISTAL END OF OTHER DEVICES USED FOR THE PROCEDURE. (B)(6). CONCOMITANT MEDICAL PRODUCTS: INTRA-PROCEDURE: HEPARIN. PRE, POST-PROCEDURE AND DISCHARGE: ASPIRIN AND CLOPIDOGREL. THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RETURNED YET. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 02424012 (NOTE: CORDIS LOT # 70810511 IS LAKE REGION LOT # 02424012). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ADMITTED ASYMPTOMATIC WITH AN 80% STENOSIS IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. AN ANGIOGUARD RX EMBOLIC PROTECTION GUIDEWIRE WAS SUCCESSFULLY DEPLOYED AND A 9 X 40MM PRECISE PRO RX WAS DEPLOYED WITH NO MALFUNCTION OR ASSOCIATE MAJOR ADVERSE EVENT. A RETRIEVAL DIFFICULTY OF THE ANGIOGUARD RX WAS EXPERIENCED, AS THE FILTER BASKET WAS NOT ABLE TO BE CLOSED. THE CAPTURE SHEATH WAS ADVANCED UNTIL THE MARKER BAND LINED UP WITH THE PROXIMAL FILTER BASKET MARKER BAND. THE FILTER BASKET DID NOT COLLAPSE INTO THE CAPTURE SHEATH. SEVERAL ATTEMPTS WERE MADE AND THE RETRIEVAL SHEATH WAS FIRMLY PUSHED ONTO BASKET. PLACED ADDITIONAL PRESSURE ON RECAPTURE SHEATH, READAVANCED, THEN REMOVED. THERE WAS NO DIFFICULTY CAPTURING THE FILTER BASKET INTO THE CAPTURE SHEATH. THERE WAS NO VISIBLE DEBRIS IN THE FILTER BASKET AFTER REMOVAL. THE USER DID NOT FEEL THAT ANY DEBRIS FROM THE FILTER BASKET ESCAPED DURING WITHDRAWAL. THE FILTER BASKET WAS NOT SUCTIONED PRIOR TO BEING WITHDRAWN INTO THE CAPTURE SHEATH. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED AND THERE WAS NO ADVERSE EVENT TO THE PATIENT. THE PATIENT WAS DISCHARGED TWO DAYS LATER WITH NO MAJOR ADVERSE EVENT.

    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 70810511

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 9 X 40MM PRECISE RX