BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2911638 · Received January 11, 2013

    Report

    Report Number
    3004939290-2013-00007
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE CARTRIDGE WAS ENGAGED TO THE HANDLE WITH THE PROCEDURAL SHEATH PULLED BACK AGAINST THE SHUTTLE. THE DEVICE WAS RECEIVED WITH THE BALLOON TIP SEVERELY INVERTED AND THE CORE WIRE BOWED. THE INVERTED BALLOON INDICATES THAT SIGNIFICANT TENSION MAY HAVE BEEN APPLIED TO THE DEVICE. THE SEALANT WAS COVERING THE BALLOON'S PROXIMAL BOND AND BLOOD WAS OBSERVED ON THE FULL LENGTH OF THE OUTER SURFACE. THE ADVANCER TUBE WAS ENGAGED TO THE DISTAL TAMP LOCK, COMPRESSING AGAINST THE SEALANT. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE DEVICE USED WAS EXPIRED (EXPIRED ON SEPTEMBER 2012). THE SAFETY AND EFFECTIVENESS OF MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F HAS NOT BEEN ESTABLISHED IN EXPIRED DEVICES. THE REVIEW OF THE LHR (LOT F1208901) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE REVIEW OF THE LHR (LOT F1208901) 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. HOWEVER, IT WAS REPORTED THAT THE DEVICE USED HAD EXPIRED ON SEPTEMBER 2012. PER THE DEVICE INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF MYNXGRIP HAVE NOT BEEN ESTABLISHED IN EXPIRED UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A (B)(6) MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F CORDIS SHEATH. PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX, PLAVIX AND ASPIRIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE APPROXIMATELY 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE SHUTTLE WAS RELEASED TO DELIVER THE SEALANT AND THE SHUTTLE HANDLE TRAVELED APPROXIMATELY 2CM THEN STOPPED. THE PHYSICIAN APPLIED ADDITIONAL FORCE TO THE SHUTTLE AND IT RELEASED INTO THE SHEATH. AS THE SEALANT MET THE END OF THE SHEATH, THE BALLOON WAS PULLED THROUGH THE ARTERY AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 30 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. THE PATIENT WAS REPORTED AS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 WITH NO CLINICAL SEQUELA NOTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18184 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1208901

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ASPIRIN| PLAVIX| ANGIOMAX