BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853476 · Received November 30, 2012

    Report

    Report Number
    3004939290-2012-00443
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS ENGAGED TO THE HANDLE AND WITH THE PROCEDURAL SHEATH PULLED BACK AGAINST THE SHUTTLE. A SEGMENT OF SEALANT WAS BUNCHED OVER THE BALLOON PROXIMAL BOND AND SOAKED WITH BLOOD. THE ADVANCER TUBE WAS LOCATED APPROXIMATELY 12MM FROM THE BALLOON PROXIMAL TIP (ENGAGED TO THE DISTAL TAMP LOCK). THE CATHETER, SHUTTLE CARTRIDGE AND ADVANCER TUBE WERE INSPECTED FOR ANOMALIES I.E. KINKS, DEFORMITY. NO ANOMALIES WERE OBSERVED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE FOR THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1227901) 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 A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED THE PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 6MM. PERI-PROCEDURE, THE PATIENT WAS GIVEN ANGIOMAX. AT THE END OF THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6/7F FOR CLOSURE. THE ACI CLINICAL SPECIALIST WAS IN ATTENDANCE AT THE CASE. THE PHYSICIAN DEPLOYED THE DEVICE PER THE IFU, HOWEVER, AS THE DEVICE WAS TAKEN OUT OF THE PATIENT, THE SEALANT REMAINED ATTACHED TO THE DEVICE. NO HEMATOMA RESULTED BUT MANUAL PRESSURE WAS HELD FOR 20 MINUTES AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS HOSPITALIZED FOR NON MYNX RELATED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1227901

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ANGIOMAX