BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2840179 · Received June 22, 2012

    Report

    Report Number
    3004939290-2012-00157
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF THE LEAK WAS A MICRO TEAR AT BALLOON, APPROXIMATELY 5 MM FROM BALLOON PROXIMAL TIP. SCRATCHES WERE NOTED LEADING TO THE TEAR IN THE BALLOON. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE TEAR COULD HAVE BEEN FROM CALCIUM. THE REVIEW OF THE LHR (F1134903) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED BY THE ACI SALES ASSOCIATE THAT AN (B)(6) FEMALE PT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNK). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL SIZE TO BE APPROXIMATELY 5 MM. PERI-PROCEDURE THE PT WAS ANTI-COAGULATED WITH HEPARIN. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AND THE BALLOON HAD NO SIGN OF A LEAK. WHEN THE PHYSICIAN GOT TO THE SECOND STOP, THE WHOLE DEVICE AND SHEATH CAME OUT WITH A BROKEN BALLOON. THE PHYSICIAN REPORTED THAT HE BELIEVES THE BROKEN BALLOON WAS CALCIUM RELATED, BUT DID NOT SEE ANY CALCIUM ON ANY OF THE PICTURES. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PT TO 20 MINUTES OF MANUAL COMPRESSION, WITH NO FURTHER COMPLICATIONS. ON (B)(6) 2012, THE ACI SALES ASSOCIATE REPORTED THAT THE PHYSICIAN CONFIRMED THAT WHEN THE DEVICE WAS REMOVED FROM THE SHEATH, ALL OF THE BALLOON PIECES WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F MGB MGB ACCESSCLOSURE, INC. MX6701 F1134903

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HEPARIN