BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2982779 · Received February 28, 2013

    Report

    Report Number
    3004939290-2013-00059
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    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, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1231302) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE ACI SALES PROFESSIONAL REPORTED THAT DURING HIS LAB VISIT AT THIS USER FACILITY THE PHYSICIAN INFORMED HIM THAT A PATIENT WHICH UNDERWENT A PERIPHERAL CATHETERIZATION PROCEDURE NOT THAT LONG AGO HAD WHAT THE PHYSICIAN CONSIDERED A MINOR COMPLICATION. THE PATIENT CALLED SEVERAL DAYS AFTER THE CATHETERIZATION PROCEDURE TO REPORT A "LUMP" IN HIS GROIN WHERE THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F HAD BEEN DEPLOYED. THE PATIENT WAS INSTRUCTED TO GO TO THE NEAREST ER TO HAVE IT CHECKED. THE ER TOLD THE PATIENT IT WAS A "SMALL" HEMATOMA (SIZE UNKNOWN). THE PATIENT CALLED BACK ON AN UNSPECIFIED TIME AND ALLEGED THAT PART OF THE SEALANT BECAME EXPOSED OUTSIDE OF HIS SKIN. THE PATIENT STATED THAT HE PULLED OUT OF HIS BODY THE REST OF THE ALLEGED SEALANT. THE PATIENT ALSO REPORTED THAT HE OBSERVED A FOUL SMELLING DISCHARGE ALONG WITH WHATEVER HE PULLED OUT FROM THE ACCESS SITE. THERE WERE NO FURTHER BLEEDING COMPLICATIONS REPORTED. THE PHYSICIAN WAS NOT OVERLY CONCERNED BUT INSTRUCTED THE PATIENT TO TREAT THE ACCESS SITE WITH ANTI-BACTERIAL CREAM UNTIL THE ACCESS SITE HEALED. THE PHYSICIAN BELIEVES THIS MIGHT HAVE BEEN A "POSSIBLE MINOR LOCAL INFECTION AT THE ACCESS SITE". NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86636 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1231302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other