BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2082660 · Received May 10, 2011

    Report

    Report Number
    9616099-2011-00316
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT PRODUCT WAS RETURNED FOR EVALUATION AND TESTING ON (B)(4) 2011. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    WHEN THE INNER POUCH WAS OPENED THE STENT WAS NOTED TO BE PREMATURELY DEPLOYED. THERE WAS NO DAMAGE NOTED TO THE INNER OR OUTER PACKAGING. THERE WAS NO DIFFICULTY OPENING THE INNER PACKAGING. THERE WAS NO DAMAGE NOTICED TO THE HANDLE OF THE DEVICE OR THE DELIVERY CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. ONE NON STERILE UNIT OF PRECISE PRO RX 5F 7X30 MM WAS RECEIVED COILED IN A PLASTIC BAG. HEMOVALVE WAS OPENED AND STENT WAS PARTIALLY DEPLOYED ABOUT 20 MM. NO OTHER DISCREPANCIES WERE FOUND DURING THE VISUAL ANALYSIS. THE USABLE LENGTH OF THE SDS CATHETER WAS MEASURED IT WAS FOUND WITHIN SPECIFICATION. THE DEPLOYMENT PROCESS WAS PERFORMED AND NO ANOMALIES WERE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE DEPLOYMENT DIFFICULTY - PREMATURE CONDITION REPORTED BY THE CUSTOMER WAS CONFIRMED DUE TO THE CONDITION OF PRODUCT AS RECEIVED, HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED SINCE NO ANOMALIES WERE FOUND DURING THE DIMENSIONAL ANALYSIS AND DEPLOYMENT PROCESS. CONTROLS EXIST IN THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT THEM IN THE SDS. PROCEDURAL FACTORS AND HANDLING MAY CONTRIBUTE TO FAILURE AS REPORTED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED, THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THIS MAY HAVE BEEN CAUSED DURING SHIPPING OR HANDLING OF THE UNIT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN.

    Description of Event or Problem · 1

    AS REPORTED BY THE MARKETING AFFILIATE, WHEN THE STENT DELIVERY SYSTEM (PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 7MM X 30MM, 135 CM) WAS OPENED FROM THE BOX THE STENT WAS FOUND OUT OF THE DISTAL END OF THE SHEATH. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE PROCEDURE BEING PERFORMED WAS A CAROTID ARTERY STENTING. THERE WAS NO DAMAGE NOTED TO THE INNER OR OUTER PACKAGING. THERE WAS NO DIFFICULTY OPENING THE INNER PACKAGING. WHEN THE PRODUCT WAS OPENED FROM THE INNER PACKAGING AND TAKEN OUTSIDE, THE STENT WAS SEEN OUTSIDE OF DISTAL END OF SHEATH. THERE WAS NO DAMAGE NOTICED TO THE HANDLE OF THE DEVICE OR THE DELIVERY CATHETER. THE STENT WAS NOT FOUND APPROPRIATE SO IT WAS NOT USED IN THE PATIENT AND A COMPETITOR'S STENT WAS DEPLOYED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA 15309799

    Patients

    Seq Age Sex Outcome Treatment
    1