BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3051385 · Received April 10, 2013

    Report

    Report Number
    3004939290-2013-00099
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1301501) 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 CLINICAL SPECIALIST THAT (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE FEMORAL HEAD VIA A 5F SHEATH (MODEL UNKNOWN). THERE WAS 1 SHEATH EXCHANGE THE SECOND SHEATH USED WAS A 6F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM AT THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE 7MM. 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 WHEN THE PHYSICIAN WITHDREW THE SHUTTLE THE ADVANCER TUBE WAS NOT VISIBLE AND THE SEALANT DID NOT DEPLOY. THE SEALANT WAS VISIBLE IN THE CATHETER. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO 30 MINUTES OF MANUAL COMPRESSION. BECAUSE THIS WAS AN INTERVENTIONAL PROCEDURE A FEMOSTOP WAS PLACED FOR 1 HOUR. THE PATIENT WAS HOSPITALIZED FOR REASONS UNRELATED TO THE MYNX DEVICE/MYNX PROCEDURE. THE PATIENT'S DISCHARGE DATE WAS NOT PROVIDED. THE ACI CLINICAL SPECIALIST CONFIRMED THAT THE ADVANCER TUBE WAS INSIDE THE SHUTTLE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148158 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1301501

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention ANGIOMAX