BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2091870 · Received May 17, 2011

    Report

    Report Number
    3004939290-2011-00108
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AND WITH NO RETURNED DEVICE, THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY 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

    ACI RECEIVED AN E-MAIL FROM A FEMALE PATIENT REGARDING A SIGNIFICANT COMPLICATION SHE EXPERIENCED AFTER UNDERGOING A CATHETERIZATION PROCEDURE IN WHICH MYNX WAS USED TO CLOSE THE FEMORAL ARTERY. ACI'S COMPLAINT HANDLING (CH) DEPARTMENT CALLED THE PATIENT ON (B)(4) 2011 AND THE PATIENT ALLEGED THAT ON (B)(6) 2011, SHE WENT INTO THE HOSPITAL FOR CARDIAC CATHETERIZATION PROCEDURE. A PREVIOUS STRESS TEST DUE TO MODERATELY ELEVATED CHOLESTEROL FOUND THAT A SMALL PORTION OF HER UPPER LEFT VENTRICLE WAS NOT FUNCTIONING PROPERLY. THE PATIENT'S PHYSICIAN ADVISED HER TO UNDERGO A DIAGNOSTIC PROCEDURE TO RULE OUT NEEDS FOR A STATIN DRUG. DURING THE PATIENT'S PROCEDURE ON (B)(6) 2011, SHE WAS PLACED UNDER SEDATION AND RECEIVED 1000 UNITS OF HEPARIN, VERSED IV 2MG AND ANOTHER UNKNOWN MEDICATION PERI-PROCEDURE. A PRE-PROCEDURAL FEMORAL ANGIOGRAM WAS TAKEN AND SHOWED NO PRESENCE OF CALCIUM, PERIPHERAL VASCULAR DISEASE (PVD), OR CALCIFICATION. THERE WAS NO COMPLICATION REPORTED DURING THE PROCEDURE OR CLOSURE. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY. SHE REPORTED THAT ON THAT DAY, SHE HAD A LUMP AT HER GROIN THE SIZE OF A "CHICKEN EGG," BUT SHE REPORTED THAT THE PHYSICIAN TOLD HER THE LUMP WILL RESOLVE ON ITS OWN. ON (B)(6) 2011, THE PATIENT ALLEGED THAT THE LUMP IN HER GROIN WAS PAINFUL AND PINK, SO ON (B)(6) 2011, SHE PRESENTED HERSELF TO THE EMERGENCY ROOM (ER) OF A DIFFERENT HOSPITAL AND WAS THERE FOR 7 HOURS. SHE ALLEGED THAT AN ULTRASOUND WAS PERFORMED AND THE PHYSICIAN RULED OUT PSEUDOANEURYSM. THE GROIN WAS DRAINED AND THE MATERIAL WAS SENT FOR CULTURE WHICH CAME BACK NEGATIVE FOR INFECTION. THE PATIENT REPORTED THAT SHE WAS PUT ON VANCOMYCIN, ADMINISTERED INTRAVENOUSLY AND WAS LATER SENT HOME. THE PATIENT ALLEGED THAT ON THE EVENING OF (B)(6) 2011, THE ACCESS SITE STARTED "LEAKING" SO SHE PRESENTED AT THE HOSPITAL IN THE EARLY MORNING HOURS OF (B)(6) 2011. THE INTERVENTIONAL CARDIOLOGIST ALLEGEDLY "PUSHED" ON THE GROIN AND REFERRED HER TO THE INFECTIOUS DISEASE DEPARTMENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A SURGERY TO DEBRIDE THE AREA, REMOVE WHAT WAS LEFT OF THE ALLEGED "MYNX," AND REPAIR THE ARTERY. THE PATIENT ALSO REPORTED THAT A WOUND VACUUM ALSO USED TO FACILITATE WOUND HEALING. THE PATIENT REPORTED THAT HER GROIN WAS VERY PAINFUL AND FOR TWO WEEKS SHE HAD HOME HEALTH AIDE (HHA) VISITING HER AS SHE WAS UNABLE TO CLEAN AND DRESS THE WOUND HERSELF. THE PATIENT LATER REPORTED THAT A VASCULAR SURGEON STATED THAT THE CLOSURE DEVICE DIDN'T CLOSE AS THE ARTERY WAS DEEP AND CLOSE TO THE BONE. 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. MX5000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention VERSED IV 2MG| HEPARIN 1000 UNITS