BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2955727 · Received February 11, 2013

    Report

    Report Number
    3004939290-2013-00044
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    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 AT THE BALLOON, APPROXIMATELY 5.5MM FROM THE BALLOON PROXIMAL TIP. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1234202) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. SEE MEDWATCH REPORT # 3004939290-2013-00043 FOR THE FIRST DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A (B)(6) FEMALE PATIENT UNDERWENT A DIAGNOSTIC PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM PRESENT AND THE VESSEL SIZE APPROXIMATELY 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AND THE BALLOON WAS CHECKED PER THE IFU. THEN THE DEVICE WAS DEPLOYED AND THE BALLOON LOST PRESSURE AS SOON AS IT REACHED THE FIRST STOP. THE DEVICE WAS REMOVED AND SINCE ACCESS WAS MAINTAINED A SECOND MYNXGRIP VASCULAR CLOSURE DEVICE 5F WAS PREPPED AND DEPLOYED. THE BALLOON FROM THE SECOND DEVICE ALSO LOST PRESSURE WHEN IT REACHED THE FIRST STOP (TIP OF THE SHEATH). THE SECOND DEVICE WAS REMOVED AND THE PHYSICIAN DECIDED TO CLOSE THE ACCESS SITE WITH ANOTHER MANUFACTURE'S CLOSURE DEVICE. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO REPORTED CLINICAL SEQUELA. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59569 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 F1234202

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR