BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840188 · Received June 28, 2012

    Report

    Report Number
    3004939290-2012-00179
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 SEALANT WAS BUNCHED OVER THE BALLOON PROXIMAL BOND. THE ADVANCER TUBE WAS LOCATED APPROXIMATELY 15 MM FROM THE BALLOON PROXIMAL TIP (ENGAGED TO THE PROXIMAL TAMP LOCK). THE CATHETER, SHUTTLE CARTRIDGE AND ADVANCER TUBE WERE INSPECTED FOR ANOMALIES (I.E. KINKS, DEFORMITY). NO ANOMALIES WERE OBSERVED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1113004) 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 SALES PROFESSIONAL THAT A MALE PT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 5F ST. JUDE SHEATH. 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 ADVANCED THE SEALANT WITH THE SHUTTLE, THEN BROUGHT THE SHEATH AND SHUTTLE UP TO THE HANDLE. THE ADVANCER TUBE WAS NOT EXPOSED AND THE SEALANT DID NOT DEPLOY. THE PHYSICIAN DEFLATED THE BALLOON, REMOVED THE DEVICE, AND CONVERTED THE PT TO MANUAL COMPRESSION (MINUTES UNKNOWN). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB, PRODUCT CODE: MGB MGB ACCESSCLOSURE, INC. MX5001 F1113004

    Patients

    Seq Age Sex Outcome Treatment
    1