BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3070426 · Received April 22, 2013

    Report

    Report Number
    9616099-2013-00241
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING THE USE OF AN EXOSEAL VASCULAR CLOSURE DEVICE, IT WAS REPORTED THAT A HEMATOMA DEVELOPED (MORE THAN 4CM) POST DEPLOYMENT REQUIRING DIGITAL PRESSURE (APPROXIMATELY 30MIN) WITH A FULLY HEPARINISED PATIENT. THE EVENT CAUSED PROLONGED BED REST TO THE PATIENT. IT WAS UNKNOWN IF HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT, HOWEVER IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE GIVEN THAT PROLONGED BED REST WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT ¿NO NURSING STAFF HAD BEEN USING THE EXOSEAL DEVICE. THE REGISTRARS USED THE PRODUCT IN SOME CASES UNDER THE SUPERVISION OF A FULLY TRAINED CORDIS CONSULTANT. THE REGISTRARS HAVE NOT COMPLETED THEIR ACCREDITATION WITH CORDIS STAFF¿. SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. 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. ACCESS SITE HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. THE EXOSEAL VASCULAR CLOSURE DEVICE PROCEDURE SHOULD BE PERFORMED BY PHYSICIANS WHO HAVE EXPERTISE IN THE TECHNIQUES OF VASCULAR CATHETERIZATION (OR OTHER HEALTHCARE PROFESSIONALS AUTHORIZED BY, OR UNDER THE DIRECTION OF, SUCH PHYSICIANS) AND POSSESS ADEQUATE TRAINING IN THE USE OF THE DEVICE, E.G. PARTICIPATION IN AN EXOSEAL CLOSURE DEVICE TRAINING PROGRAM. PATIENT, PHARMACOLOGICAL AND/OR PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS TO THIS EVENT. THE INFORMATION DOES NOT SUGGEST A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE EVENT; THEREFORE NO 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

    DURING THE USE OF AN EXOSEAL VASCULAR CLOSURE DEVICE, IT WAS REPORTED THAT A HEMATOMA DEVELOPED (MORE THAN 4CM) POST DEPLOYMENT REQUIRING DIGITAL PRESSURE (APPROXIMATELY 30MIN) WITH A FULLY HEPARINZED PATIENT. THE EVENT CAUSED PROLONGED BED REST TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173009 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization