BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2991719 · Received March 6, 2013

    Report

    Report Number
    3004939290-2013-00074
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED VIA A 7F SHEATH (MODEL UNKNOWN). FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PHYSICIAN PULLED BACK TO THE ARTERIOTOMY AND AS THE PHYSICIAN WAS PREPARING TO SHUTTLE DOWN; THE BALLOON PULLED THROUGH THE ARTERIOTOMY AND OUT OF THE VESSEL ALONG WITH THE SHEATH. THE PHYSICIAN DEFLATED THE BALLOON AND REMOVED THE DEVICE COMPLETELY OUT OF THE PATIENT. THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION FOR APPROXIMATELY 15 MINUTES AND A CLAMP DEVICE WAS APPLIED TO THE ACCESS SITE WITH NO FURTHER COMPLICATIONS NOTED. IT IS UNKNOWN IF THE PATIENT WAS HOSPITALIZED, BUT IT WAS NOTED THAT THE PATIENT DID NOT HAVE TO BE HOSPITALIZED DUE TO THE MYNX DEVICE/PROCEDURE. IT WAS ALSO REPORTED THAT UPON FURTHER INSPECTION OF THE DEVICE ONCE IT WAS OUTSIDE OF THE PATIENT IT WAS NOTED THAT THE BALLOON DID NOT APPEAR TO BE RUPTURED. THE PHYSICIAN STATED HE BELIEVES THAT THE VESSEL WAS CALCIFIED. THE ACI SALES PROFESSIONAL CONFIRMED THAT THE PHYSICIAN HAD TO DEFLATE THE BALLOON TO REMOVE THE DEVICE THE REST OF THE WAY THROUGH THE TISSUE TRACT AND FULLY OUT OF THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96230 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN