BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2498696 · Received March 21, 2012

    Report

    Report Number
    1058196-2012-00128
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 27, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A NEUROVASCULAR PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE ENTERPRISE VRD AND DELIVERY SYSTEM THROUGH THE PROWLER SELECT PLUS 150/5 CM 45 SHAPE MICROCATHETER (MC). THE MC AND STENT WERE REMOVED FROM THE PATIENT AND ANOTHER STENT AND MC WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON STERILE ENTERPRISE AND DELIVERY WIRE WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS RECEIVED IN IT'S ORIGINAL POSITION INSERTED IN THE INTRODUCER TUBE. THE DELIVERY WIRE PRESENTED NO DAMAGES. THE INVOLVED PROWLER SELECT PLUS MICROCATHETER (MC) WAS RECEIVED IN OTHER PLASTIC BAG FOR ANALYSIS. SOME WAVES WERE NOTED ON THE MC; HOWEVER, THESE APPEAR TO HAVE OCCURRED DURING THE HANDLING OF THE DEVICE FOR RETURN. THE MC AND ENTERPRISE SYSTEM PRESENTED WITH NO OTHER VISUAL DAMAGES. THE ID FROM THE MC WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. NO OTHER ANOMALIES WERE OBSERVED ON THE RECEIVED UNITS. NO DEVICE DAMAGES WERE NOTED WITH MICROSCOPIC EXAMINATION. THE FUNCTIONAL ANALYSIS WAS PERFORMING ACCORDING TO PROCEDURE; THE RETURNED ENTERPRISE WAS INTRODUCED INTO THE MC AND IT WAS ABLE TO GO THROUGH THE MC WITHOUT ANY RESISTANCE OR FRICTION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH PROWLER SELECT PLUS LOT 15499223 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF ENTERPRISE LOT 10085956. 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. THE REPORTED INABILITY TO ADVANCE THE ENTERPRISE VRD SYSTEM THROUGH THE PROWLER SELECT PLUS WAS NOT CONFIRMED WITH ANALYSIS OF THE RETURNED DEVICES. IN ADDITION, WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY REVIEW OF THE DEVICES THERE IS NO INDICATION OF ANY MANUFACTURING DEFECT OR ANOMALY CONTRIBUTING TO THE REPORTED EVENT. PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2012-00127 AND #1058196-2012-00128.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2012-00127 AND #1058196-2012-00128.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A NEUROVASCULAR PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE ENTERPRISE VRD AND DELIVERY SYSTEM THROUGH THE PROWLER SELECT PLUS 150/5 CM 45 SHAPE MICROCATHETER (MC). THE PHYSICIAN USED ANOTHER STENT AND MICROCATHETER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15499223

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE VRD AND DELIVERY