BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3191912 · Received June 27, 2013

    Report

    Report Number
    3004939290-2013-00160
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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 VASCULAR CLOSURE SPECIALIST THAT A FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PROCEDURE ON (B)(4) 2013. ACCESS WAS OBTAINED AT THE LEFT COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT AFTER THE DEVICE WAS DEPLOYED, THE PATIENT EXPERIENCED A HEMATOMA GREATER THAN 6CM AT THE ACCESS SITE. MANUAL COMPRESSION WAS APPLIED TO THE HEMATOMA FOR 15 MINUTES. THE PATIENT WAS KEPT FOR 2 HOURS IN OBSERVATION IN THE OUTPATIENT AREA, WHERE THE PROCEDURE TOOK PLACE. SINCE THE ACCESS SITE DID NOT GO DOWN AFTER THE 2 HOURS, THE PATIENT WAS SENT TO THE ER TO BE CHECKED IN FOR OBSERVATION OVERNIGHT (DUE TO THE HEMATOMA). THERE WERE NO FURTHER COMPLICATIONS NOTED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292895 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O