BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840172 · Received June 19, 2012

    Report

    Report Number
    3004939290-2012-00147
    Event Type
    Malfunction
    Date Received
    June 19, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 LONGITUDINAL TEAR IN THE BALLOON DISTAL TIP, APPROXIMATELY 6.5 MM FROM BALLOON PROXIMAL TIP. NO OTHER SOURCE OF A LEAK WAS IDENTIFIED. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (F1209305) 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 AN (B)(6) MALE 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 REVEALED PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL SIZE TO BE APPROXIMATELY 6-7 MM. PERI-PROCEDURE, THE PT WAS ANTI-COAGULATED WITH HEPARIN. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. THE PHYSICIAN USED A BUDDY WIRE WITH 50/50 CONTRAST. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE, AND THE DEVICE CAME STRAIGHT THROUGH THE SHEATH. THE PHYSICIAN REPORTED THAT HE "DIDN'T FEEL THE 1ST OR 2ND STOP". THE DEVICE WAS REMOVED AND ACCESS WAS MAINTAINED, DUE TO THE USE OF THE BUDDY WIRE. A SECOND DEVICE WAS PREPPED AND DEPLOYED SUCCESSFULLY. HEMOSTASIS WAS ACHIEVED. THE PT WAS REPORTED AS HOSPITALIZED (NOT MYNX RELATED). NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1209305

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR HEPARIN