BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 3000715 · Received March 12, 2013

    Report

    Report Number
    3004939290-2013-00084
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    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

    THE ACI SALES PROFESSIONAL REPORTED THAT HE RECEIVED A CALL REGARDING A PATIENT WHICH UNDERWENT AN INTERVENTIONAL PERIPHERAL CATHETERIZATION PROCEDURE ON (B)(6) 2013. FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS A TRAINED USER, SELECTED A MYNXGRIP VASCULAR CLOSURE DEVICE 5F FOR CLOSURE. IT WAS REPORTED THAT POST CLOSURE AN OCCLUSION WAS NOTED. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL WHERE THE OCCLUSION WAS ATTEMPTED TO BE REMOVED PERCUTANEOUSLY BUT IT WAS UNSUCCESSFUL. A THROMBOLYTIC WAS INFUSED. THE INFUSION WAS NOT SUCCESSFUL EITHER SO A SURGEON WAS CONSULTED. THE SURGEON PERFORMED SURGERY TO REMOVE THE OCCLUSION AND INITIALLY THOUGHT THE SURGERY WAS A SUCCESS. DURING THE HOSPITAL STAY THE PATIENT'S LEFT FOOT WAS NOTED TO HAVE MORE NECROSIS AND THE SURGEON PERFORMED A BELOW THE KNEE AMPUTATION ON (B)(6) 2013. THE ACI SALES PROFESSIONAL WAS INFORMED THAT THEY WILL UPDATE HIM ON THE STATUS OF THE PATIENT. ON (B)(6) 2013, THE ACI SALES PROFESSIONAL REPORTED THAT THE MYNXGRIP VASCULAR CLOSURE DEVICE WAS DEPLOYED ON THE LEFT LEG AND THE AMPUTATION OCCURRED ON THE LEFT LEG. IT IS UNKNOWN AT THIS TIME IF THE SEALANT WAS DEPLOYED INTRAVASCULARLY. THE VASCULAR SURGEON NOTED THAT PLAQUE AND THROMBUS WAS REMOVED FROM THE ARTERY, BUT THERE WASN'T A COMMENT ON THE PLACEMENT OF THE SEALANT. (B)(6) 2013: THE ACI SALES PROFESSIONAL STATED THAT THE PHYSICIAN BELIEVES THAT THE AMPUTATION WAS RELATED TO THE MYNX PROCEDURE, ALTHOUGH NO "PEG" MATERIAL WAS CONFIRMED TO BE IN THE PATIENT'S ARTERY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103692 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S