BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840171 · Received June 20, 2012

    Report

    Report Number
    3004939290-2012-00152
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS ENGAGED TO THE HANDLE, AND WITH THE PROCEDURAL SHEATH PULLED BACK AGAINST THE SHUTTLE. THE ADVANCER TUBE WAS LOCATED APPROXIMATELY 15MM FROM THE BALLOON PROXIMAL TIP. THE SEALANT WAS FOUND WEDGED BETWEEN THE PROXIMAL TIP OF THE ADVANCER TUBE AND THE SHUTTLE CARTRIDGE. IT IS UNK WHETHER THE LOCATION OF THE SEALANT WAS DUE TO USER MANIPULATION OR SUBSEQUENT HANDLING. THE CATHETER, SHUTTLE CARTRIDGE, AND ADVANCER TUBE WERE INSPECTED FOR ANOMALIES. NO ANOMALIES WERE OBSERVED. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (F1115701) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A (B)(6), UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED JUST ABOVE THE BIFURCATION, VIA A 5F SHEATH (MODEL UNK), AND "WENT DOWN TO BALLOON THE SFA." A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE APPROXIMATELY 6 MM. PERI-PROCEDURE THE PT WAS ANTI-COAGULATED WITH HEPARIN. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PHYSICIAN WAS DEPLOYING THE DEVICE, AND PUSHED THE GRAY SHUTTLE HANDLE DOWN. WHEN THE PHYSICIAN PULLED THE SHEATH BACK, THE WHITE ADVANCER TUBE DID NOT ENGAGE. THE PHYSICIAN DEFLATED THE BALLOON, AND CONVERTED THE PT TO 20 MINUTES OF MANUAL COMPRESSION. THE PT'S GROIN "LOOKED GOOD". HEMOSTASIS WAS ACHIEVED. THE PT WAS AMBULATED AND DISCHARGED HOME THE SAME DAY ((B)(6) 2012). NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5001 F1115701

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HEPARIN