BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3844932 · Received June 3, 2014

    Report

    Report Number
    9616099-2014-00362
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE AGE OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE EXOSEAL DEVICE WAS NOT DEPLOYED IN THE VESSEL. IT DEPLOYED ON ITS OWN (WITHOUT THE PHYSICIAN DEPRESSING THE BUTTON) AND WAS STILL VISIBLE IN THE CATHETER 3/4 OF THE WAY EXPOSED. THE PHYSICIAN HELD PRESSURE AND THERE WAS NO INCIDENT THAT LED TO ANY PATIENT COMPLICATIONS. COMPLAINT CONCLUSION: DURING THE USE OF A 5F EXOSEAL DEVICE FOR VASCULAR CLOSURE, IT WAS REPORTED THAT ¿THE DEVICE DEPLOYED ON ITS OWN WITHOUT THE BUTTON BEING DEPRESSED.¿ MANUAL PRESSURE WAS USED AT THE END OF THE PROCEDURE TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. A RETROGRADE APPROACH WAS USED FOR THE PROCEDURE. THE VCD SHOWED NO VISIBLE SIGNS OF DAMAGE AND WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. IT WAS STATED BY THE ACCOUNT THAT ¿THE DEVICE WAS NOT DEPLOYED INTRAVASCULARLY.¿ UPON REMOVAL OF THE EXOSEAL FROM THE PATIENT THE PLUG WAS NOTED ¿STILL VISIBLE IN THE CATHETER THREE QUARTERS OF THE WAY EXPOSED.¿ ¿THE PHYSICIAN HAD PROCEEDED TO DEPRESS THE BUTTON AFTER REALIZING THE DEVICE HAD ALREADY BEEN DEPLOYED.¿ THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD AND HAS USED THE DEVICE MANY TIMES PRIOR TO THIS CASE. MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL. ONE NON-STERILE 5F EXOSEAL WAS RECEIVED INSIDE A PLASTIC BAG. THE DEPLOYMENT LEVER WAS FULLY DEPLOYED. THE INDICATOR WINDOW WAS RECEIVED IN BLACK/WHITE AND RED POSITION. THE GUARD WAS FULLY DEPRESSED. THE PLUG WAS NOT RECEIVED WITH RETURNED DEVICE. THE PLUG WAS FULLY DEPLOYED. THERE WERE BLOOD RESIDUES OBSERVED IN THE RETURNED DEVICE. A CORDIS 5F CATHETER SHEATH INTRODUCER WAS RECEIVED WITH THE RETURNED DEVICE. THE TRIGGER WAS PROPERLY ASSEMBLED INTO CASE. NO OTHER ANOMALIES WERE OBSERVED WITH THE MECHANISM. DURING FUNCTIONAL ANALYSIS IT WAS FOUND THAT THE LOCK OUT PLATE CAN BE PUSHED BACK AND FORWARD. INNER DIAMETER OF DELIVERY SHAFT WAS MEASURED AND FOUND WITHIN DIMENSIONAL SPECIFICATION. THE FAILURE VASCULAR CLOSURE DEVICE (VCD) DEPLOYMENT DIFFICULTY-PREMATURE/IN PATIENT WAS NOT CONFIRMED DURING ANALYSIS SINCE THE TRIGGER WAS FOUND PROPERLY ASSEMBLED INTO CASE AND NO OTHER ANOMALIES WERE OBSERVED IN THE MECHANISM. THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF LOT 15986279 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED COMPLAINT ¿VASCULAR CLOSURE DEVICE-DEPLOYMENT DIFFICULTY/PREMATURE IN PATIENT¿ COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. THE IFU CAUTIONS THE FOLLOWING; WHILE HOLDING THE EXOSEAL VCD IN THE RIGHT HAND, MAKING SURE THE THUMB IS NOT PLACED ON THE PLUG DEPLOYMENT BUTTON, CONTINUE RETRACTING THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER VERY SLOWLY (CONTROLLING RETRACTION WITH THE LEFT HAND) UNTIL THE GRAPHIC PATTERN IN THE INDICATOR WINDOW CHANGES TO A SOLID BLACK COLOR, AT WHICH POINT THE PLUG IS CORRECTLY POSITIONED FOR DEPLOYMENT. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE WERE NO ANOMALIES NOTED OF THE DEVICE PRIOR TO USE. IT IS POSSIBLE THAT HANDLING FACTORS DURING THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE IS AS FOLLOWS: ONE NON STERILE 5F EXOSEAL WAS RECEIVED INSIDE A PLASTIC BAG. THE DEPLOYMENT LEVER WAS FULLY DEPLOYED. THE INDICATOR WINDOW WAS RECEIVED IN BLACK/WHITE AND RED POSITION. THE GUARD WAS FULLY DEPRESSED. THE PLUG WAS NOT RECEIVED WITH RETURNED DEVICE. THE PLUG WAS FULLY DEPLOYED. THERE WERE BLOOD RESIDUES OBSERVED IN THE RETURNED DEVICE. A CORDIS 5F CATHETER SHEATH INTRODUCER WAS RECEIVED WITH THE RETURNED DEVICE. THE TRIGGER WAS PROPERLY ASSEMBLED IN TO CASE. NO OTHER ANOMALIES OBSERVED IN THE MECHANISM. DURING FUNCTIONAL ANALYSIS IT WAS FOUND THAT THE LOCK OUT PLATE CAN BE PUSHED BACK AND FORWARD. INNER DIAMETER OF DELIVERY SHAFT WAS MEASURED AND FOUND WITHIN DIMENSIONAL SPECIFICATION. REVIEW OF LOT 15986279 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE FAILURE VASCULAR CLOSURE DEVICE (VCD) DEPLOYMENT DIFFICULTY-PREMATURE/IN PATIENT WAS NOT CONFIRMED DURING ANALYSIS SINCE THE TRIGGER WAS FOUND PROPERLY ASSEMBLY IN TO CASE AND NO OTHER ANOMALIES WERE OBSERVED IN THE MECHANISM. THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING USE OF A 5F EXOSEAL DEVICE FOR VASCULAR CLOSURE, IT WAS REPORTED THAT THE DEVICE DEPLOYED ON ITS OWN WITHOUT THE BUTTON BEING DEPRESSED. THE PHYSICIAN DEPRESSED THE BUTTON ANYWAYS AFTER HE KNEW IT WAS DEPLOYED. MANUAL PRESSURE WAS HELD TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. A RETROGRADE APPROACH WAS USED FOR THE PROCEDURE. THE PHYSICIAN HAD ACHIEVED CERTIFICATION ON THE USE OF EXOSEAL VCD AND HAS USED THE DEVICE MANY TIMES PRIOR TO THIS CASE. THE VCD SHOWED NO VISIBLE SIGNS OF DAMAGE AND WAS PREPPED ACCORDING TO IFU INSTRUCTIONS. THE DEVICE WAS NOT DEPLOYED INTRAVASCULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324111 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15986279

    Patients

    Seq Age Sex Outcome Treatment
    1