BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840262 · Received April 24, 2012

    Report

    Report Number
    3004939290-2012-00092
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR DIFFICULTY RETRACTING THE SHEATH. HOWEVER, THE INTRODUCER SHEATH WAS NOT RETURNED; THEREFORE, A COMPLETE PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE RETURNED DEVICE WAS VISUALLY INSPECTED FOR ANOMALIES AND ANY DEFORMITY THAT MAY HAVE OBSTRUCTED THE DEVICE PATH DURING DEPLOYMENT. NO ANOMALIES WERE OBSERVED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE REPORTED SHEATH RETRACTION JAM COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1129104) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A FEMALE PATIENT WHO IS IN HER 60'S AND WEIGHS (B)(6), UNDERWENT A DIAGNOSTIC PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY. A PRE-PROCEDURAL FEMORAL ANGIOGRAM REVEALED EVIDENCE OF CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. THE PHYSICIAN REPORTED THAT HE HAD DIFFICULTY RETRACTING THE SHEATH; THEREFORE, THE PHYSICIAN ABORTED USING THE DEVICE AND CONVERTED THE PATIENT TO 15 MINUTES OF MANUAL COMPRESSION. THE PATIENT WAS REPORTED AS RELEASED TO HOME THE SAME DAY WITH NO FURTHER COMPLICATIONS. IT WAS ALSO REPORTED THAT THE SEALANT REMAINED ON THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB ACCESSCLOSURE, INC. MX5001 F1129104

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR