BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2991830 · Received March 6, 2013

    Report

    Report Number
    3004939290-2013-00077
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 8, 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 F1301602) INDICATED THAT THE DEVICE 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) MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. 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 PATIENT WAS DISCHARGED AFTER THE PROCEDURE WITH NO COMPLICATIONS NOTED. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE ER WITH A RIGHT COLD FOOT. THE PULSES IN THE RIGHT FOOT WERE CHECKED AND CONFIRMED TO BE DECREASED. A CT ANGIOGRAM WAS PERFORMED WHICH SHOWED MATERIAL IN THE PT/TIBIAL TRUNK WHICH WAS BELIEVED TO BE "SEALANT". THE PATIENT WAS TAKEN TO THE SURGERY ROOM WHERE AN EMBOLECTOMY WAS PERFORMED. FLOW TO THE RIGHT FOOT WAS RESTORED. TWO DAYS AFTER THE SURGERY THE PATIENT WAS DISCHARGED TO HOME. THE PATIENT WAS REPORTED AS HAVING GOOD FLOW TO HER RIGHT FOOT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96287 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1301602

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R ANGIOMAX