BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 2241954 · Received September 9, 2011

    Report

    Report Number
    9616099-2011-00720
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 16, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE 7 FRENCH EXOSEAL VASCULAR CLOSURE DEVICE WAS INSERTED AND APPEARED TO HAVE HEMOSTASIS. THE PATIENT COLLAPSED ON RETURN TO WARD. RESUSCITATION WAS PERFORMED AND REQUIRED FOUR (4) UNITS OF BLOOD AND EMERGENCY SURGERY. THE PATIENT WAS STABLE AND WAS DISCHARGED. THE PATIENT WAS RE-ADMITTED TO ANOTHER HOSPITAL BUT WAS APPARENTLY OKAY. THE PATIENT WAS STABLE AND WAS DISCHARGED. THE PATIENT HAD A LARGE HEMATOMA IN OTHER GROIN FROM PREVIOUS ANGIOGRAM. THE PRODUCT WAS DISCARDED; THEREFORE, WILL NOT BE RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS TO GET ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ADDITIONAL INFORMATION WILL BE REPORTED AS IT BECOMES AVAILABLE. 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. 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 7 FRENCH EXOSEAL VASCULAR CLOSURE DEVICE WAS INSERTED AND APPEARED TO HAVE HEMOSTASIS. THE PATIENT COLLAPSED ON RETURN TO WARD. RESUSCITATION WAS PERFORMED AND REQUIRED FOUR (4) UNITS OF BLOOD AND EMERGENCY SURGERY. THE PATIENT WAS STABLE AND WAS DISCHARGED. THE PATIENT WAS RE-ADMITTED TO ANOTHER HOSPITAL BUT WAS APPARENTLY OKAY. THE PATIENT WAS STABLE AND WAS DISCHARGED. THE PATIENT HAD A LARGE HEMATOMA IN OTHER GROIN FROM PREVIOUS ANGIOGRAM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A 7FR 11CM TERUMO SHEATH INTRODUCER WAS USED. THERE WAS NO RESISTANCE/FRICTION WITH THE CSI. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING WITH AN AUDIBLE CLICK. THERE WAS ADEQUATE BLEED-BACK SIGNAL. THE PROPER INDICATION WAS SHOWN IN THE INDICATOR WINDOW. THE DEPLOYMENT BUTTON FULLY DEPRESSED AND THE PLUG DEPLOYED. THE PHYSICIAN HAD DONE APPROXIMATELY 15 CASES BEFORE. MULTIPLE ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE REASON FOR THE COLLAPSE AND EMERGENCY SURGERY WERE UNSUCCESSFUL. THE PRODUCT WAS DISCARDED; THEREFORE, WILL NOT BE 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 EVENTS REPORTED. 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

    ADDENDUM RECEIVED 12/1/2011: A 7FR 11CM TERUMO SHEATH INTRODUCER WAS USED. THERE WAS NO RESISTANCE/FRICTION WITH THE CSI. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING WITH AN AUDIBLE CLICK. THERE WAS ADEQUATE BLEED-BACK SIGNAL. THE PROPER INDICATION WAS SHOWN IN THE INDICATOR WINDOW. THE DEPLOYMENT BUTTON FULLY DEPRESSED AND THE PLUG DEPLOYED. THE VCD WAS NOT REMOVED WITH THE SHEATH AS A SINGLE UNIT. COMMENTS STATED THAT THE EXOSEAL HAD "FALLEN OFF."

    Description of Event or Problem · 1

    THE 7 FRENCH EXOSEAL VASCULAR CLOSURE DEVICE WAS INSERTED AND APPEARED TO HAVE HEMOSTASIS. THE PATIENT COLLAPSED ON RETURN TO WARD. RESUSCITATION WAS PERFORMED AND REQUIRED FOUR (4) UNITS OF BLOOD AND EMERGENCY SURGERY. THE PATIENT WAS STABLE AND WAS DISCHARGED. THE PATIENT WAS RE-ADMITTED TO ANOTHER HOSPITAL BUT WAS APPARENTLY OKAY. THE PATIENT WAS STABLE AND WAS DISCHARGED. THE PATIENT HAD A LARGE HEMATOMA IN OTHER GROIN FROM PREVIOUS ANGIOGRAM. THE PRODUCT WAS DISCARDED; THEREFORE, WILL NOT BE RETURNED FOR ANALYSIS.

    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