BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 6906835 · Received October 2, 2017

    Report

    Report Number
    3004939290-2017-00375
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    June 8, 2017
    Report Date
    September 30, 2017
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INTEGRATION OF ACCESSCLOSURE, INC. INTO THE CORDIS BUSINESS MODEL, THE DETERMINATION WAS MADE THAT REPORTABILITY FOR PRODUCT FAILURE MODES WOULD BE ALIGNED WITH CURRENT REPORTABILITY FOR CORDIS PRODUCTS. THIS DECISION TO ALIGN REPORTABILITY WAS MADE, AS THE SAID FAILURE MODES, WOULD NOT RESULT IN PATIENT INJURY. AS A RESULT, THIS EVENT IS BEING FILED BEYOND THE 30-DAY FDA REQUIREMENT. (B)(4). COMPLAINT CONCLUSION: IT WAS REPORTED THAT AFTER COMPLETELY SHUTTLING DOWN A MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) AND RETRACTING THE SHEATH, THE ADVANCER TUBE WAS MISSING. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON COULD NOT BE RETRACTED, EVEN THOUGH IT APPEARED DEFLATED THROUGH THE WHITE SHEATH. EVERYTHING WAS PULLED TOGETHER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT F1706903 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED EVENT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. BASED ON LIMITED INFORMATION AVAILABLE FOR REVIEW, CONTRIBUTING FACTORS TO THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, PROCEDURAL FACTORS ARE LIKELY. AS PER THE INSTRUCTIONS FOR USE, ¿WHILE PULLING LIGHTLY ON THE DEVICE HANDLE (TO ENSURE THE BALLOON IS ABUTTING THE ARTERIOTOMY OR VENOTOMY), OPEN THE PROCEDURAL SHEATH STOPCOCK AND CONFIRM TEMPORARY HEMOSTASIS. DETACH SHUTTLE AND ADVANCE IN A CONTINUOUS MOTION UNTIL A DEFINITIVE STOP IS FELT. IMMEDIATELY GRASP THE PROCEDURAL SHEATH AND WITHDRAW IT FROM THE TISSUE TRACT. CONTINUE RETRACTING UNTIL THE SHUTTLE LOCKS ON THE HANDLE.¿ THE DHR REVIEW DOES NOT SUGGEST THAT THE FAILURE EXPERIENCED BY THE CUSTOMER IS RELATED TO THE MYNX MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    THIS CASE IS TO CAPTURE THE COMPLAINT "ANOTHER FAILURE WAS NOTED FROM A DIFFERENT OCCASION, AFTER SHUTTLING DOWN THE ADVANCER TUBE WAS MISSING WHEN THE SHEATH WAS RETRACTED AND THE SHUTTLE LOCKED ONTO THE HANDLE, WHILE USING A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD). THERE WAS NO PATIENT INJURY. THE PRODUCT IS NOT AVAILABLE. THERE WERE NO ANOMALIES OR DAMAGES NOTED WHEN THE DEVICE WAS REMOVED FROM PACKAGE. THE DEVICE PREPPED NORMALLY. THERE ADVANCER TUBE WAS NOT VISIBLE. THE USER DID SHUTTLE DOWN COMPLETELY. THE DEPLOYER WAS CERTIFIED ON MYNX DEVICES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686510 MYNXGRIP VASCULAR CLOSURE DEVICE 5F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX5021 F1706903

    Patients

    Seq Age Sex Outcome Treatment
    1