BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840071 · Received June 14, 2012

    Report

    Report Number
    3004939290-2012-00146
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 17, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A LONGITUDINAL TEAR IN THE BALLOON, APPROX 5 MM FROM THE BALLOON PROXIMAL TIP. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1210902) 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) FEMALE PT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY (CFA) 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 MM. PERI-PROCEDURE, THE PT WAS ANTICOAGULATED WITH 6500 UNITS OF 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 50/50 CONTRAST. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE BEFORE THE BALLOON REACHED THE ARTERIOTOMY. IT WAS REPORTED THAT THE PHYSICIAN REPORTED THAT THE BALLOON POSSIBLY LOST PRESSURE FROM THE PLAQUE PRESENT IN THE CFA. THE DEVICE WAS REMOVED AND SINCE ACCESS WAS MAINTAINED, A SECOND DEVICE WAS PREPPED AND USED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PT WAS AMBULATED AND DISCHARGED HOME THE SAME DAY ((B)(6) 2012). NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB, PRODUCT CODE: MGB MGB ACCESSCLOSURE, INC. MX6721 F1210902

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR 6500 UNITS OF HEPARIN