BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3172052 · Received June 17, 2013

    Report

    Report Number
    9616099-2013-00367
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 22, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED BASED ON NEW INFORMATION RECEIVED. COMPLAINT CONCLUSION: AFTER USE OF AN EXOSEAL DEVICE FOR VASCULAR CLOSURE, THE PATIENT EXPERIENCED DISCOMFORT AT THE INDECISION SITE AND THE EXOSEAL WAS REMOVED SURGICALLY. THE PATIENT HAD AN EXOSEAL PLUG DEPLOYED IN A NON-ACUTE CARE OUTPATIENT FACILITY. THE PATIENT WAS DISCHARGED POST RECOVERY. AT AN UNKNOWN TIME, THE PATIENT RETURNED WITH COMPLAINTS OF LEG DISCOMFORT AT INCISION SITE AND THE PHYSICIAN BELIEVED THAT THE PLUG MAY BE LIMITING BLOOD FLOW IN THE FEMORAL ARTERY. THEREFORE, THE PHYSICIAN DISSECTED DOWN AT THE ACCESS/CLOSURE SITE AND REMOVED THE EXOSEAL PGA PLUG. THERE WERE NO SIGNS OF INFECTION, INFLAMMATION OR ALLERGIC REACTION. PATIENT WAS DISCHARGED IN STABLE CONDITION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT A LOT NUMBER, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE PRODUCT RETURNED FOR EVALUATION, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PHYSICIAN CLOSED GROIN WITH AN EXOSEAL VASCULAR CLOSURE DEVICE LAST WEEK. PHYSICIAN INFORMED THE REPRESENTATIVE ON (B)(6) 2013 THAT HIS COLLEAGUE HAD TO REMOVE THE EXOSEAL PLUG FROM THE PATIENT. IT IS NOT CLEAR IF THE EXOSEAL PLUG WAS REMOVED FROM THE ACCESS SITE OR FROM INSIDE THE ARTERY. FURTHER INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    ADDENDUM: ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2013, THE PATIENT WAS CLOSED WITH EXOSEAL VASCULAR IN THE NON-ACUTE CARE OUTPATIENT FACILITY. PATIENT WAS DISCHARGED POST RECOVERY. PATIENT CAME BACK WITH LEG DISCOMFORT AT INCISION SITE AND BELIEVED THAT THE PLUG MAY BE LIMITING BLOOD FLOW IN THE FEMORAL ARTERY. THEREFORE, THE PHYSICIAN DISSECTED DOWN AT THE ACCESS/CLOSURE SITE AND REMOVED THE EXOSEAL PGA PLUG. THERE WERE NO SIGNS OF INFECTION, INFLAMMATION OR ALLERGIC REACTION. PATIENT WAS DISCHARGED AND IS DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273067 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R