BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840208 · Received June 27, 2012

    Report

    Report Number
    3004939290-2012-00168
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 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

    THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR (LOT F1212202) INDICATED THAT THE MYNX 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 (B)(6) MALE PT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY, VIA A 5F SHEATH (MODEL UNK). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL SIZE TO BE APPROXIMATELY 6 MM. PERI-PROCEDURE THE PT WAS ANTICOAGULATED WITH 2,000 UNITS OF HEPARIN. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE DEVICE, AND DELIVERED THE SEALANT TO THE ARTERY. AS THE PHYSICIAN WAS PULLING BACK THE SHEATH TO EXPOSE THE SEALANT, THE SHEATH CAME OUT OF THE TRACT (APPROXIMATELY 1 CM), THEN STOPPED AND WOULD NOT COME BACK TO THE GREEN HANDLE. ALSO THE DEVICE SHUTTLE TUBE WOULD NOT COME BACK TO THE BLACK HANDLE. THE PHYSICIAN HELD AROUND THE ACCESS SITE WHILE THE TECH WIGGLED THE SHEATH AND GENTLY PULLED BACK. THE SHEATH FINALLY CAME BACK, BUT THE PHYSICIAN HAD ALREADY INJURED THE ARTERY. MANUAL COMPRESSION WAS APPLIED FOR 10 MINUTES. HEMOSTASIS WAS ACHIEVED. THERE WAS NO HEMATOMA. THE PT WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 F1212202

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 2,000 UNITS OF HEPARIN