BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3183370 · Received June 21, 2013

    Report

    Report Number
    3004939290-2013-00154
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 F1303902) 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 SALES PROFESSIONAL THAT A PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED VIA A 6F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE 5MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN (TRAINING STATUS UNCONFIRMED) SELECTED A MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT AFTER 2 MINUTES OF POST HOLD, A 4 INCH X 4 INCH IN SIZE HEMATOMA WAS NOTED. THE HEMATOMA WAS AROUND THE ACCESS SITE AND DISTAL TO THE ACCESS SITE. MANUAL COMPRESSION WAS HELD FOR 30 MINUTES AT WHICH TIME THE HEMATOMA WAS RESOLVED. THE PATIENT WAS THIN BUT NOT ENOUGH FOR THE SEALANT TO STICK OUT OF THE TISSUE TRACK. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO CLINICAL SEQUELA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282324 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1303902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other