BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840253 · Received May 24, 2012

    Report

    Report Number
    3004939290-2012-00111
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH THE CATHETER CUT AND THE SHUTTLE CARTRIDGE WAS SEPARATED FROM THE CATHETER. DUE TO THE DISSECTED AND SEPARATE DEVICE COMPONENTS, THE PROBABLE CAUSE OF THE REPORTED DEVICE DEPLOYMENT JAM COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1207603) INDICATED THAT THE DEVICE 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 PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO EVIDENCE OF PVD/CALCIUM WITHIN THE VICINITY OF THE PUNCTURE SITE, AND THE VESSEL SIZE TO BE APPROXIMATELY 7 MM. THE PATIENT WAS ANTICOAGULATED WITH ANGIOMAX PRE-PROCEDURE. FOLLOWING THE PROCEDURE, THE PHYSICIAN, WHO IS A TRAINED USER, USED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE PUNCTURE SITE. IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS SHUTTLING DOWN TO DELIVER THE SEALANT THE DEVICE JAMMED. THE PHYSICIAN REMOVED THE DEVICE AND THEN CONVERTED THE PATIENT TO 20 MINUTES OF MANUAL COMPRESSION. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO REPORTED CLINICAL SEQUELA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1207603

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ANGIOMAX