BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3172457 · Received June 17, 2013

    Report

    Report Number
    9616099-2013-00368
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REVIEW, IT WAS NOTED THE PRODUCT ANALYSIS/DEVICE EVALUATION WAS NOT INCLUDED IN THE PREVIOUSLY SUBMITTED SUPPLEMENTAL MDR. CC UPDATED TO INCLUDE FAL REPORT: THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING DEPLOYMENT OF A 6 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD), THE DEVICE WAS INSERTED INTO THE (UNKNOWN) SHEATH. THE SHEATH WAS RETRACTED AND LOCKED INTO THE COLLAR OF THE EXOSEAL DEVICE. DURING RETRACTION OF THE SHEATH AND EXOSEAL VCD, THE INDICATOR WINDOW TURNED BLACK INSTANTLY AND WOULD NOT CHANGE BACK TO WHITE. THE EXOSEAL DEVICE WAS REMOVED AND THE DEPLOYMENT PROCESS WAS STARTED AGAIN WITH A NEW EXOSEAL VCD. THE NEW EXOSEAL DEVICE FUNCTIONED CORRECTLY. HEMOSTASIS WAS ACHIEVED SUCCESSFULLY WITH THE NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO CLARIFY THE EVENT WERE UNSUCCESSFUL. ONE NON-STERILE 6F EXOSEAL WAS RECEIVED INSIDE A PLASTIC BAG. THE DEPLOYMENT LEVER WAS FULLY DEPRESSED. THE INDICATOR WINDOW WAS RECEIVED IN BLACK AND WHITE POSITION. THE GUARD WAS DEPRESSED. THE INDICATOR WIRE WAS RETRACTED. THE PLUG WAS FULLY DEPLOYED. THE PLUNGER DISC WAS RECEIVED ALIGNED TO DELIVERY SHAFT. NO OTHER ANOMALIES WERE RECEIVED IN THE RETURNED DEVICE. THE GAP BETWEEN THE LOCK OUT PLATE AND THE INDICATOR WINDOW WAS OBSERVED (AS EXPECTED). NO OBSTRUCTIONS, LOOSE OR BROKEN PARTS WERE OBSERVED. FUNCTIONAL ANALYSIS WAS PERFORMED AND THE INDICATOR WINDOW ACHIEVED ON DIFFERENT POSITIONS: BLACK/BLACK AND BLACK/WHITE/RED POSITIONS AS EXPECTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE IFU INDICATES THAT DURING RETRACTION OF THE EXOSEAL DEVICE AND THE SHEATH AS A SINGLE UNIT IT IS IMPORTANT TO ENSURE THAT THE OPERATOR¿S THUMB IS NOT PLACED OR RESTING ON THE PLUG DEPLOYMENT BUTTON (PER PROCEDURE STEP 7 IN THE EXOSEAL INSTRUCTIONS FOR USE). 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. IN THIS CASE, THE WINDOW CHANGED TO SOLID BLACK UPON RETRACTION OF THE DEVICES AS PER IFU, HOWEVER IT IS UNKNOWN IF THE CHANGE OF THE INDICATOR WINDOW COINCIDED OR NOT WITH THE EXPECTED REDUCTION OF PULSATILE FLOW INDICATING OPTIMAL TIME FOR PLUG DEPLOYMENT. ADDITIONALLY, ONCE THE EXOSEAL IS LOCKED INTO THE SHEATH (AN AUDIBLE ¿CLICK¿ IS HEARD), UPON REMOVAL OF THE EXOSEAL FROM THE PATIENT, THE SHEATH IS ALSO REMOVED BECAUSE IT IS ATTACHED TO IT. IN THIS CASE, IT IS UNKNOWN IF THE FIRST EXOSEAL WAS SECURELY ATTACHED TO THE SHEATH. HOWEVER THE REPORTER INDICATED THAT IT WAS REMOVED AND A SECOND EXOSEAL USED. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT REPORTED. HOWEVER, IT IS POSSIBLE THAT THE COMPLAINT DEVICE WAS NOT ATTACHED TO THE SHEATH GIVEN THAT IT COULD BE REMOVED AND ANOTHER EXOSEAL USED WITH THE SAME SHEATH. THE DEVICE RECEIVED FOR EVALUATION HAD THE DEPLOYMENT BUTTON PRESSED AND DID NOT CONTAIN THE PLUG. THE FAILURE REPORTED BY THE CUSTOMER ¿INDICATOR WINDOW INCORRECT INDICATION¿ COULD NOT BE CONFIRMED SINCE INDICATOR GRAPHIC AND LENS GRAPHIC WERE FOUND WITHIN SPECIFICATION AND INDICATOR WINDOW WAS ACHIEVES DIFFERENT POSITIONS DURING FUNCTIONAL TEST. 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 Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING DEPLOYMENT OF A 6 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD), THE DEVICE WAS INSERTED INTO THE (UNKNOWN) SHEATH. THE SHEATH WAS RETRACTED AND LOCKED INTO THE COLLAR OF THE EXOSEAL DEVICE. DURING RETRACTION OF THE SHEATH AND EXOSEAL VCD, THE INDICATOR WINDOW TURNED BLACK INSTANTLY AND WOULD NOT CHANGE BACK TO WHITE. THE EXOSEAL DEVICE WAS REMOVED AND THE DEPLOYMENT PROCESS WAS STARTED AGAIN WITH A NEW EXOSEAL VCD. THE NEW EXOSEAL DEVICE FUNCTIONED CORRECTLY. HEMOSTASIS WAS ACHIEVED SUCCESSFULLY WITH THE NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO CLARIFY THE EVENT AND OBTAIN THE PRODUCT FOR EVALUATION WERE UNSUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE IFU INDICATES THAT DURING RETRACTION OF THE EXOSEAL DEVICE AND THE SHEATH AS A SINGLE UNIT IT IS IMPORTANT TO ENSURE THAT THE OPERATOR¿S THUMB IS NOT PLACED OR RESTING ON THE PLUG DEPLOYMENT BUTTON (PER PROCEDURE STEP 7 IN THE EXOSEAL INSTRUCTIONS FOR USE). 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. IN THIS CASE, THE WINDOW CHANGED TO SOLID BLACK UPON RETRACTION OF THE DEVICES AS PER IFU, HOWEVER IT IS UNKNOWN IF THE CHANGE OF THE INDICATOR WINDOW COINCIDED OR NOT WITH THE EXPECTED REDUCTION OF PULSATILE FLOW INDICATING OPTIMAL TIME FOR PLUG DEPLOYMENT. ADDITIONALLY, ONCE THE EXOSEAL IS LOCKED INTO THE SHEATH, UPON REMOVAL OF THE EXOSEAL FROM THE PATIENT, THE SHEATH IS ALSO REMOVED BECAUSE IT IS ATTACHED TO IT. IN THIS CASE, IT IS UNKNOWN HOW THE FIRST EXOSEAL WAS DETACHED FROM THE SHEATH IN ORDER TO USE THE SECOND EXOSEAL. 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. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING DEPLOYMENT OF A 6 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD), THE DEVICE WAS INSERTED INTO THE (UNKNOWN) SHEATH. THE SHEATH WAS RETRACTED AND LOCKED INTO THE COLLAR OF THE EXOSEAL DEVICE. DURING RETRACTION OF THE SHEATH AND EXOSEAL VCD, THE INDICATOR WINDOW TURNED BLACK INSTANTLY AND WOULD NOT CHANGE BACK TO WHITE. THE EXOSEAL DEVICE WAS REMOVED AND THE DEPLOYMENT PROCESS WAS STARTED AGAIN WITH A NEW EXOSEAL VCD. THE NEW EXOSEAL DEVICE FUNCTIONED CORRECTLY. HEMOSTASIS WAS ACHIEVED SUCCESSFULLY WITH THE NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273208 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15738025

    Patients

    Seq Age Sex Outcome Treatment
    1