BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2882777 · Received December 20, 2012

    Report

    Report Number
    3004939290-2012-00478
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF LEAK WAS A LONGITUDINAL TEAR AT THE BALLOON, APPROXIMATELY 5MM FROM THE BALLOON PROXIMAL TIP. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED. HOWEVER, IT WAS REPORTED THAT THE "BALLOON RUPTURED AS IT CAME IN CONTACT WITH THE SHEATH" AND DAMAGE WAS OBSERVED IN THE DISTAL TIP OF THE INTRODUCER SHEATH. THE REVIEW OF THE LHR (LOT F1227704) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. SEE MEDWATCH REPORT 3004939290-2012-00480 FOR THE SECOND DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED BELOW THE FEMORAL HEAD AND BIFURCATION VIA A 6F TERUMO SHEATH. PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH ASPIRIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. THE DEVICE WAS PREPPED PER THE IFU. IT WAS REPORTED THAT THE "BALLOON RUPTURED AS IT CAME IN CONTACT WITH THE SHEATH". THE DEVICE WAS REMOVED AND SINCE ACCESS WAS MAINTAINED THE PHYSICIAN PREPPED AND DEPLOYED A SECOND MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F. THE BALLOON FROM THE SECOND DEVICE ALSO "RUPTURED AS IT CAME IN CONTACT WITH THE SHEATH". THE SECOND DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO 20 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1227704

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ASPIRIN