BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PROWLER CATALOG NUMBER

    MDR report key: 2740065 · Received September 11, 2012

    Report

    Report Number
    1058196-2012-00350
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS DIFFICULTY ADVANCING THE ENTERPRISE VRD SYSTEM NEAR THE DISTAL HALF OF THE PROWLER SELECT PLUS MICROCATHETER. AFTER THREE FAILED ATTEMPTS TO ADVANCE THE ENTERPRISE SYSTEM AND MICROCATHETER WERE WITHDRAWN FROM THE PATIENT AND THEN THE STENT WAS RELEASED OUT OF THE MICROCATHETER. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SAME PROWLER SELECT PLUS WAS THEN USED SUCCESSFULLY WITH ANOTHER ENTERPRISE VRD. IT WAS INDICATED THAT THERE WAS NO ASSOCIATED ADVERSE EVENT. ONE NON STERILE ENTERPRISE VRD AND DELIVERY SYSTEM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS RECEIVED DEPLOYED. ALSO, AN INTRODUCER TUBE WAS RECEIVED. THE INVOLVED MICRO CATHETER WAS NOT RECEIVED. THE ENTERPRISE STENT WAS OBSERVED UNDER A MICROSCOPE AND NO FRACTURES NOR OTHERS ANOMALIES WERE OBSERVED. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED SINCE THE STENT WAS RETURNED DEPLOYED. THE INVOLVED PROWLER SELECT PLUS WAS NOT RETURNED AND AS REPORTED IT WAS USED SUCCESSFULLY WITH ANOTHER ENTERPRISE VRD AFTER THE REPORTED EVENT. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10086313. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THERE WERE NO DAMAGES FOUND ON THE RETURNED STENT OR DELIVERY SYSTEM. IT WAS CONFIRMED THAT THE STENT WAS DEPLOYED AFTER REMOVAL FROM THE PATIENT AS REPORTED. IT IS POSSIBLE THAT PROCEDURAL FACTORS/VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE RESISTANCE/FRICTION, HOWEVER, BASED ON THE AVAILABLE INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE; NO CONCLUSION CAN BE MADE. THE DEVICE DID NOT PRESENT WITH ANY MANUFACTURING DEFECT OR ANOMALY THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PROCEDURAL TECHNIQUE OF WITHDRAWING THE ENTERPRISE SYSTEM FROM THE MICROCATHETER AFTER REMOVAL FROM THE PATIENT WITHOUT HAVING THE INTRODUCER FULLY SEATED IN THE HUB WOULD HAVE RESULTED IN DEPLOYMENT OF THE STENT. WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY RELATIONSHIP TO THE MANUFACTURING PROCESS. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, PROCEDURAL FACTORS MAY HAVE IMPACTED THE EVENT WITH NO INDICATION OF ANY RELATED MANUFACTURING DEFECTS OR ANOMALIES; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE USED: 6F ENVOY GUIDEWIRE, PROWLER SELECT PLUS MICROCATHETER, 6F CORDIS SHEATH. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    DOCTOR FOUND IT WAS SO HARD TO ADVANCE HALFWAY NEAR THE DISTAL OF MICROCATHETER. HE TRIED THREE TIMES, ALL FAILED. THEN WITHDREW THE STENT SYSTEM AND MICROCATHETER FROM THE PATIENT. THE STENT HAD BEEN RELEASED OUT OF MICROCATHETER. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE INDICATED THAT IT WAS VERIFIED PRIOR TO INSERTION THAT STENT WAS CONTAINED WITHIN THE OUTER SHEATH/INTRODUCER OF THE SYSTEM. THE GUIDEWIRE PORT WAS FLUSHED AS OUTLINED IN THE IFU PRIOR TO LOADING ON THE GUIDEWIRE. THE GUIDEWIRE USED WAS A 6F ENVOY AND A 6F CORDIS SHEATH. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS. RESISTANCE WAS ENCOUNTERED AS THE STENT SEPARATED WITHIN THE MICROCATHETER DURING RETRIEVAL. NO ADDITIONAL INTERVENTION WAS PERFORMED TO RETRIEVE THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PROWLER CATALOG NUMBER CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1