BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2081714 · Received May 9, 2011

    Report

    Report Number
    3004939290-2011-00105
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 12, 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, THE 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 (B)(6) MALE PATIENT WITH A HISTORY OF RECENT MULTI-VESSEL PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DRUG-ELUTING STENTS TO THE LEFT ANTERIOR DESCENDING, CIRCUMFLEX, AND RIGHT CORONARY ARTERIES, UNDERWENT HIS FIRST PCI PROCEDURE IN (B)(6) (EXACT TIMEFRAME IS UNKNOWN). IT WAS REPORTED THAT THE 6/7F MYNX WAS USED FOR FEMORAL ARTERIAL CLOSURE. THERE WAS NO REPORT OF FEVER, CHILLS, OR PAIN AT THE SITE PRIOR TO AMBULATION AND DISCHARGE. ON (B)(6) 2011, THE PATIENT WAS ADMITTED AT THE HOSPITAL AFTER THE PATIENT PRESENTED WITH A COMPLAINT OF SEROSANGUINEOUS DRAINAGE FROM HIS RIGHT GROIN ARTERIOTOMY SITE. THE SITE WAS EVALUATED BY THE INFECTIOUS DISEASE AND VASCULAR SURGERY. REPORTEDLY, THE PATIENT UNDERWENT A RIGHT GROIN ULTRASOUND WHICH DEMONSTRATED NO AV FISTULA, NO PSEUDOANEURYSM, NO HEMATOMA, AND NO EXTRA ARTERIAL FLUID COLLECTION. THE INFECTIOUS DISEASE CONSULTATION PRESCRIBED INTRAVENOUS ANTIBIOTICS (NAME UNKNOWN). A VASCULAR SURGEON PERFORMED A SMALL INCISION AND DRAINAGE OF THE SITE BEDSIDE WITH EXPRESSION OF THE PURULENT FLUID. THE SITE WAS CULTURED,HOWEVER THE CULTURE WAS UNABLE TO BE PERFORMED DUE TO SCANT MATERIAL OBTAINED FROM THE CULTURE. BLOOD CULTURES WERE NEGATIVE FOR INFECTION. THE PATIENT WAS REPORTED TO BE STABLE AND UPON DISCHARGE, THE PATIENT WAS TRANSITIONED TO ORAL ANTIBIOTICS (KEFLEX 500 MG 3 TIMES A DAY FOR 7 DAYS AND DOXYCYCLINE 100 MG TWICE A DAY FOR 7 DAYS). THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2011, HAS A FOLLOW-UP APPOINTMENT WITH HIS PRIMARY CARE PHYSICIAN 2 WEEKS POST DISCHARGE.

    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 63 YR Hospitalization| R