BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 5919589 · Received August 31, 2016

    Report

    Report Number
    3004939290-2016-00227
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    August 9, 2016
    Report Date
    August 10, 2016
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE FACILITY RECENTLY SWITCHED TO ST. JUDE PROCEDURAL SHEATHS AND HAVE HAD "MULTIPLE ITEMS GETTING STUCK IN THE SHEATH, CATHETERS, CTO DEVICES, ETC;" HOWEVER, IT IS NOT LIKELY THAT THE PROCEDURAL SHEATH WOULD CAUSE THE BALLOON TO BECOME STUCK INSIDE THE ADVANCER TUBE OF THE MYNX DEVICE. THE REVIEW OF THE LHR (F1616801) INDICATED THAT THERE WERE NO REWORKS OR RELATED NON-CONFORMANCES (NCMRS) FOR THIS LOT. THE LOT MET ALL PRODUCT SPECIFICATIONS, INCLUDING QUALITY CONTROL ACCEPTANCE CRITERIA AND STERILIZATION PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED, THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MDR WILL BE FILED. REFER TO 3004939290-2016-00228, 3004939290-2016-00229, 3004939290-2016-002230, AND 3004939290-2016-002231 FOR THE RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 MYNXGRIP DEVICE BALLOONS FROM THE SAME LOT BECAME STUCK IN THE ADVANCER TUBE UPON AN ATTEMPT TO RETRACT THE BALLOON FROM THE ADVANCER TUBE AFTER DEFLATION DURING 5 SEPARATE CASES. THE DEVICE WAS BEING USED FOR ARTERIAL CLOSURE. AT PREP, THE BLACK MARKER ON THE INFLATION INDICATOR WAS FULLY EXPOSED. THE STOPCOCK WAS OPENED WHEN THE BALLOON WAS AT THE ARTERIOTOMY. RESISTANCE WAS NOT FELT WHILE INSERTING THE DEVICE. RESISTANCE WAS FELT WHILE PULLING THE BALLOON BACK TO THE ARTERIOTOMY. UNUSUAL FORCE WAS NOT APPLIED WHILE SHUTTLING DOWN OR DURING RETRACTION. THE DEVICE DEPLOYED THE SEALANT WITH NO ISSUES. AFTER THE BALLOON BECAME SUCK, THE DEVICE WAS REMOVED FROM THE PATIENT WITH THE WIRE AND BALLOON STILL IN THE ADVANCER TUBE. MANUAL COMPRESSION WAS APPLIED FOR 30 MINUTES OR LESS TO ACHIEVE HEMOSTASIS. THE PATIENT'S HOSPITALIZATION WAS NOT PROLONGED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THIS TIME. THIS REPORT IS 1 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568981 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX6721 F1616801

    Patients

    Seq Age Sex Outcome Treatment
    1