BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 4213494 · Received October 30, 2014

    Report

    Report Number
    9616099-2014-00704
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    November 19, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE IFU. PRIOR TO USE, IT WAS NOTED THAT THERE WAS A DEFECT. THE PREMATURE DEPLOYMENT OCCURRED DURING THE PREPPING OF THE DEVICE. THIS WAS A STENTING PROCEDURE TO THE CAROTID ARTERY. THE PROCEDURE WAS COMPLETED BY A USING A NEW PRECISE STENT. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PARTIAL PRE-MATURE STENT DEPLOYMENT OCCURRED DURING PREPARATION OF THE STENT DELIVERY SYSTEM. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE IFU. THE PROCEDURE WAS COMPLETED BY A USING A NEW PRECISE STENT. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THERE WAS NO REPORT OF PATIENT INJURY. ONE NON-STERILE PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 7MM X 40MM, 135 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. UNIT WAS RECEIVED PARTIALLY DEPLOYED (6MM). HEMOSTASIS VALVE WAS RECEIVED CLOSED. NO OTHER DISCREPANCIES WERE FOUND. THE USABLE LENGTH WAS MEASURED AND FOUND WITHIN SPECIFICATION. FUNCTIONAL TEST (DEPLOYMENT PROCESS) WAS PERFORMED ACCORDING TO PROCEDURE AND NO ANOMALIES WERE FOUND. REVIEW OF LOT 16046882 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE FAILURE ¿SDS - DEPLOYMENT DIFFICULTY-PREMATURE/DURING PREP¿ REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED SINCE DURING DIMENSIONAL AND FUNCTIONAL ANALYSES NO ANOMALIES WERE FOUND. CONTROLS ARE IN PLACE AT THE FINAL ASSEMBLY AND PACKAGING PROCESS TO DETECT THIS KIND OF ISSUE. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING PROCESS. THEREFORE NO ACTIONS WERE TAKEN. THE HEMOVALVE OF THE PRECISE PRO RX IS SHIPPED IN THE OPEN POSITION. IF THE PREPPING INSTRUCTIONS ARE NOT PROPERLY FOLLOWED AND THE VALVE IS NOT CLOSED PRIOR TO REMOVAL FROM THE TRAY IT IS POSSIBLE TO PRE-MATURELY DEPLOY THE STENT OR TO START STENT DEPLOYMENT WHILE STILL IN THE TRAY OR DURING REMOVAL FROM THE TRAY. IT IS POSSIBLE THAT THE OPERATOR'S INTERACTION WITH THE SDS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT IF THESE STEPS WERE NOT FOLLOWED CORRECTLY. HOWEVER, BASED ON THE INFORMATION PROVIDED NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    DURING THE IRRIGATION, THE SHEATH RETURNED BACK AND CAUSED THE RELEASE OF A PRECISE STENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695860 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS NIM CORDIS CORPORATION PC0740XCE 16046882

    Patients

    Seq Age Sex Outcome Treatment
    1