BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 4258155 · Received November 14, 2014

    Report

    Report Number
    3004939290-2014-00163
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    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. THE REVIEW OF THE LHR (LOT F1301401) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. 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. SEE MDR 3004939290-2014-000164 FOR SECOND DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F CORDIS AVANTI SHEATH. PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE 7MM. 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 BALLOON RUPTURED DURING PULLBACK AT THE FIRST STOP. THE DEVICE WAS REMOVED AND A SECOND MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F WAS DEPLOYED. THE BALLOON FROM THE SECOND DEVICE WAS MAINTAINED A DEVICE FROM ANOTHER MANUFACTURER WAS DEPLOYED SUCCESSFULLY. 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
    735852 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1301401

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR ANGIOMAX