BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 2801672 · Received October 23, 2012

    Report

    Report Number
    9616099-2012-00607
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED INDICATED THAT 8 HOURS AFTER USE OF AN EXOSEAL DEVICE FOR VASCULAR CLOSURE, THE PATIENT EXPERIENCED COLDNESS IN THE LEG. THE PLUG WAS REMOVED FROM THE POPLITEAL ARTERY AND THE EVENT RESOLVED. THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT EIGHT HOUR AFTER THE INDEX PROCEDURE, THE PATIENT OBSERVED A COLD LEG. A MRI WAS MADE AND THE PLUG COULD BE REMOVED FROM THE POPLITEAL ARTERY BY A SMALL VESSEL SECTION THE SAME DAY. AS PER THE AFFILIATE, NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THE PHYSICIAN HAS USED THE DEVICE APPROXIMATELY 100 TIMES PREVIOUSLY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE IFU PROVIDES THE FOLLOWING CAUTION: (XI.7) IF THE GRAPHIC PATTERN IN THE INDICATOR WINDOW DOES NOT CHANGE TO A SOLID BLACK COLOR AFTER APPROXIMATELY 1CM OF RETRACTION FROM THE POINT THAT PULSATILE FLOW SIGNIFICANTLY SLOWED OR HAS STOPPED, DISCONTINUE THE USE OF THE DEVICE. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. PERIPHERAL ARTERY OCCLUSION AND LOWER EXTREMITY ARTERIAL EMBOLI ARE LISTED AS SERIOUS POTENTIAL RISKS ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT EIGHT HOUR AFTER THE INDEX PROCEDURE, THE PATIENT OBSERVED A COLD LEG. A MRI WAS MADE AND THE PLUG COULD BE REMOVED FROM THE POPLITEAL ARTERY BY A SMALL VESSEL SECTION THE SAME DAY. AS PER THE AFFILIATE, NO FURTHER INFORMATION IS AVAILABLE AS THE HOSPITAL IS UNWILLING TO GIVE FURTHER DETAILS APART FROM THE FACT, THAT THE PATIENT IS FINE. THE LOT NUMBER IS UNKNOWN. THE PHYSICIAN HAS USED THE DEVICE APPROXIMATELY 100 TIMES PREVIOUSLY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R