BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 4233326 · Received November 6, 2014

    Report

    Report Number
    3004939290-2014-01005
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH THE INTRODUCER SHEATH SEPARATED FROM THE DEVICE HANDLE. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE SEALANT WAS FLUSH WITH THE DISTAL END OF THE SEALANT SLEEVE. WHEN AN ATTEMPT WAS MADE TO RETRACT THE SEALANT SLEEVE, SIGNIFICANT RESISTANCE WAS NOTED. IT WAS OBSERVED THAT THE SEALANT GRIP TIP WAS STUCK TO THE CATHETER AND THE SEALANT WAS SWELLED SLIGHTLY WHICH COULD PREVENT RETRACTION OF THE SEALANT SLEEVE. IF THE SEALANT SLEEVE MOVEMENT WAS RESTRICTED THAT WOULD EXPLAIN THE RESISTANCE FELT DURING CATHETER ADVANCEMENT. IF THE DEVICE WAS EXPOSED TO AN ELEVATED TEMPERATURE, THE SEALANT GRIP TIP MAY HAVE ADHERED TO THE POLYIMIDE SHAFT OR THE SEALANT SLEEVE, WHICH COULD LEAD TO A DEVICE JAM. THE INTRODUCER SHEATH WAS INSPECTED FOR ANOMALIES THAT MAY HAVE OBSTRUCTED THE DEVICE PATH DURING DEVICE INSERTION. NO ANOMALIES WERE OBSERVED. THE REVIEW OF THE LHR (LOT F1425806) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE FOLLOWING INFORMATION: FEMORAL ACCESS, CALCIFICATION PRESENT ON THE RIGHT ILIAC, THE DEPLOYER WAS UNABLE TO ADVANCE THE DEVICE INTO THE MYNX ACE SHEATH, THE MYNX PROCEDURE WAS ABORTED, MANUAL PRESSURE WAS HELD FOR 15-20 MINUTES WITH NO FURTHER COMPLICATIONS NOTED. THE PATIENT WAS NOT HOSPITALIZED DUE TO THE MYNX DEVICE/MYNX PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. TYPE OF PROCEDURE: LEFT HEART CATH. ACCESS WAS OBTAINED ON THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713844 MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6740 F1425806

    Patients

    Seq Age Sex Outcome Treatment
    1