BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2170716 · Received July 21, 2011

    Report

    Report Number
    3004939290-2011-00163
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT ACI IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY (RCFA) VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM REVEALED NO PRESENCE OF DISEASE IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, WITH THE ALPHA MYNX TRAINER (AMT) PRESENT, CHOSE THE DEVICE TO CLOSE THE FEMORAL ARTERY. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE DEVICE AND ONCE THE BALLOON WAS AGAINST THE ARTERIOTOMY, THE PHYSICIAN ADVANCED THE SHUTTLE TUBE TOWARDS THE PROCEDURAL SHEATH. HE THEN WITHDREW THE SHEATH TO EXPOSE THE ADVANCER TUBE. HOWEVER, PULSATILE BLOOD FLOW WAS NOTED TO BE COMING OUT OF PROXIMAL END OF THE ADVANCER TUBE. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PATIENT TO 5 MINUTES OF MANUAL COMPRESSION AND CONTINUED TO HOLD PRESSURE FOR ANOTHER 15 MINUTES WHILE TRANSFERRING THE PATIENT TO THE HOLDING AREA. IN THE HOLDING AREA, THE PATIENT COMPLAINED OF BACK PAIN. A COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN WAS PERFORMED WHICH CONFIRMED A RETROPERITONEAL BLEED (RPH). THE PATIENT WAS TRANSFUSED WITH ONE UNIT OF BLOOD ON (B)(6) 2011 AND ANOTHER UNIT ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT WAS ONLY GIVEN UNKNOWN PAIN MEDICATION. IT WAS ALSO REPORTED THAT THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2011 WITH NO 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. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O