BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1020662 · Received March 27, 2008

    Report

    Report Number
    3004939290-2008-00020
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. PER THE MYNX IFU, THE MYNX IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH. IN ADDITION, THE SAFETY AND EFFECTIVENESS OF MYNX HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE PUNCTURE.

    Description of Event or Problem · 1

    A FEMALE WITH HISTORY OF PVD AND RIGHT OSTIAL SFA STENOSIS UNDERWENT A LEFT SFA AND RIGHT ILIAC INTERVENTION IN 2008. AN 8.5 F SHEATH WAS PLACED INTO THE CFA WITH AN EXCHANGE TO AN 8F SHORT SHEATH DURING THE PROCEDURE. ALTHOUGH THE MYNX IS INDICATED FOR USE WITH 6F OR 7F PROCEDURAL SHEATHS, THE PHYSICIAN PROCEEDED TO USE THE MYNX CLOSURE DEVICE, IN WHICH IT WAS REPORTED THAT THE PHYSICIAN HAD A HARD TIME ACHIEVING TEMPORARY HEMOSTASIS WITH THE BALLOON. THE DEVICE WAS DEPLOYED, HOWEVER, THERE WAS A FAILURE TO ACHIEVE HEMOSTASIS AND A FEMSTOP WAS APPLIED. LATER THAT NIGHT, THE PATIENT HAD COMPLAINTS OF PAIN/NUMBNESS IN THE RIGHT LOWER EXTREMITY. THE PATIENT WAS ADMINISTERED ANGIOMAX, REOPRO AND TPA, AND UNDERWENT A SUCCESSFUL THROMBECTOMY/REVASCULARIZATION OF THE SFA VIA CONTRALATERAL ACCESS, HOWEVER, DUE TO A BLEED AT THE CFA ACCESS SITE, A PATCH ANGIOPLASTY WAS ALSO PERFORMED. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED 48 HOURS LATER WITHOUT FURTHER INCIDENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. MX6700 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention