BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2170735 · Received July 21, 2011

    Report

    Report Number
    3004939290-2011-00162
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON LOSS OF PRESSURE SEEMS TO HAVE BEEN OR MAY HAVE BEEN CAUSED BY A LONGITUDINAL TEAR APPROXIMATELY 5.5 MM FROM BALLOON PROXIMAL TIP. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1109106) INDICATED THAT THE MYNX 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 PATIENT UNDERWENT A PERIPHERAL INTERVENTION PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY (CFA) VIA A 5F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM WAS TAKEN AND IT REVEALED A MILDLY CALCIFIED ARTERY. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE TO CLOSE THE FEMORAL ARTERY. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED AND WHEN THE PHYSICIAN PULLED BACK THE BALLOON AGAINST THE ARTERIOTOMY, THE BALLOON RUPTURED. SINCE ACCESS WAS NOT LOST, THE PHYSICIAN PREPPED AND DEPLOYED A 2ND MYNX DEVICE, HOWEVER ANOTHER BALLOON RUPTURE OCCURRED UPON PULLBACK. THE DEVICE WAS REMOVED AND THE PHYSICIAN CONVERTED THE PATIENT TO MANUAL COMPRESSION. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED PER HOSPITAL PROTOCOL WITHOUT REPORT OF CLINICAL SEQUELA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX5001 F1109106

    Patients

    Seq Age Sex Outcome Treatment
    1