BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1923972 · Received December 14, 2010

    Report

    Report Number
    3004939290-2010-00132
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 24, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 CAUSE OF THE INFECTION WITH PAIN AND SWELLING COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THEREFORE, THERE IS NO INDICATION THAT THE MYNX DEVICE DID NOT PERFORM PER SPECIFICATION OR AS INTENDED. PLUS, THERE WAS NO INFORMATION PROVIDED REGARDING THE PRE-PROCEDURAL FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE. ADDITIONALLY, THE MYNX IS TERMINALLY STERILIZED AND SUBJECTED TO LAL (LIMULUS AMEBOCYTE LYSATE) TESTING TO ENSURE THE PRODUCT MEETS STERILIZATION AND BACTERIAL ENDOTOXIN REQUIREMENTS, PRIOR TO EACH LOT BEING RELEASED FOR COMMERCIAL USE. THE IFU ALSO STATES: THE FOLLOWING ADVERSE REACTIONS OR CONDITIONS MAY ALSO BE ASSOCIATED WITH MYNX OR WITH THE DIAGNOSTIC OR INTERVENTIONAL PROCEDURE: ALLERGIC REACTION, FOREIGN BODY REACTION, INFECTION, INFLAMMATION, OR VESSEL LACERATION. 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

    A (B)(6) MALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE, HYPERCHOLESTEROLEMIA, DIABETES, ARTHRITIS, DIVERTICULAR DISEASE, PRIOR HERNIA REPAIR AND ROTATOR CUFF REPAIR UNDERWENT RIGHT CORONARY ARTERY STENTING ON (B)(6) 2010. FOLLOWING THE PROCEDURE, THE PHYSICIAN, A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. THERE WAS NO REPORT OF COMPLICATION DURING THE PROCEDURE OR CLOSURE. THE FOLLOWING DAY ((B)(6) 2010), THE PATIENT WAS DISCHARGED HOME. FOLLOWING DISCHARGE (EXACT TIMEFRAME UNKNOWN), THE PATIENT DEVELOPED REDNESS, PAIN AND SWELLING OF THE PUNCTURE SITE AND PRESENTED TO THE ER ON (B)(6) 2010 WITH EVIDENCE OF WHAT WAS BELIEVED TO BE AN INFECTION. HOWEVER, THERE WAS NO SIGN OF DISCHARGE OBSERVED AT THE PUNCTURE SITE. A PHYSICAL EXAM REVEALED NO GALLOP OR HEART MURMUR. THE PATIENT'S LUNGS WERE CLEAR AND HE HAD NO PEDAL EDEMA. THE PATIENT WAS SEEN BY A VASCULAR SURGEON AND DOPPLER IMAGES OF THE RIGHT FEMORAL ARTERY WERE NEGATIVE FOR PSEUDOANEURYSM. THE PATIENT ALSO UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS WHICH WAS REMARKABLE FOR POST-PROCEDURE HEMORRHAGE/CELLULITIS IN THE RIGHT GROIN BUT WITHOUT ANY DISCRETE ABSCESS. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. ON (B)(6) 2010, THE PATIENT DEVELOPED SOME DISCHARGE FROM THE RIGHT GROIN. THE GROIN WAS DRAINED AT BEDSIDE AND WHAT WAS ASSESSED TO BE MYNX MATERIAL (PEG) WAS EXPRESSED. THE DISCHARGE FROM THE WOUND SITE WAS CULTURED AND IT WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS AND DISCHARGED HOME WITH NO FURTHER CLINICAL SEQUELA. IT WAS REPORTED THAT THE WOUND IS HEALING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention