BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 2220425 · Received August 23, 2011

    Report

    Report Number
    9616099-2011-00655
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 25, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT WHILE PREPARING FOR VASCULAR CLOSURE, THE PHYSICIAN NOTED THAT THE PACKAGING SEAL FOR THE 6 FR. EXOSEAL VCD (VASCULAR CLOSURE DEVICE) WAS OPEN. THE OUTER PACKAGING WAS NOT DAMAGED UPON INSPECTION AND WAS SAID TO HAVE BEEN RECEIVED IN THIS CONDITION. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS SAID TO HAVE NOT BEEN PARTIALLY OPENED AND PUT BACK ON THE SHELF. THE PRODUCT WAS NOT CLINICALLY USED IN THE PATIENT. THE PHYSICIAN USED ANOTHER EXOSEAL DEVICE TO COMPLETE THE VASCULAR CLOSURE. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE 6F EXOSEAL WAS RECEIVED IN ITS ORIGINAL PACKAGE. THE PACKAGE WAS FOUND OPEN FROM THE SUPPLIER SEAL (CHEVRON); THE SEAL APPEARS AS IF IT HAS BEEN PREVIOUSLY OPENED SINCE EVIDENCE OF TRANSFERRED MATERIAL WAS FOUND IN THE SEAL SECTION. NO DAMAGES WERE NOTED IN THE CORDIS SEAL AND THE OTHER TWO SEALS. 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 FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER CONTROLS ARE PLACED IN THE MANUFACTURING LINES TO PREVENT DEFECTIVE POUCHES FROM LEAVING THE FACILITY ACCORDING TO (B)(4). ALSO RECEIVING INSPECTIONS TEAM PERFORMS A PULL TEST ACCORDING TO (B)(4). NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING RELATED; THEREFORE NO ACTIONS WERE TAKEN. THE COMPLAINT OF COMPROMISED STERILITY WAS CONFIRMED ON ANALYSIS; HOWEVER, THE EXACT CAUSE OF THE CONFIRMED FAILURE COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. REVIEW OF THE INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT WHILE PREPARING FOR VASCULAR CLOSURE, THE PHYSICIAN NOTED THAT THE PACKAGING SEAL FOR THE 6 FR EXOSEAL VCD (VASCULAR CLOSURE DEVICE) WAS OPEN. THE OUTER PACKAGING WAS NOT DAMAGED UPON INSPECTION AND WAS SAID TO HAVE BEEN RECEIVED IN THIS CONDITION. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS SAID TO HAVE NOT BEEN PARTIALLY OPENED AND PUT BACK ON THE SHELF. THE PRODUCT WAS NOT CLINICALLY USED IN THE PATIENT. THE PHYSICIAN USED ANOTHER EXOSEAL DEVICE TO COMPLETE THE VASCULAR CLOSURE. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15351825

    Patients

    Seq Age Sex Outcome Treatment
    1