BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1923998 · Received December 14, 2010

    Report

    Report Number
    3004939290-2010-00134
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. IT WAS REPORTED THAT THE PATIENT'S WHITE BLOOD CELL COUNT WAS ELEVATED INDICATING A POSSIBLE INFECTION. HOWEVER, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT A CULTURE ANALYSIS, THE CAUSE OF THE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. THERE WAS NO INFORMATION PROVIDED REGARDING THE PRE-PROCEDURAL FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE, OR ANY INFORMATION PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX AND ITS USE PER THE INSTRUCTIONS FOR USE. THERE IS NO INDICATION THAT THE DEVICE DID NOT PERFORM PER SPECIFICATION OR AS INTENDED. 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. PLUS, 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. IN ADDITION, BASED ON THE LIMITED PATIENT AND PROCEDURE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE CAUSE OF THE HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED. NO INFORMATION WAS PROVIDED REGARDING ANY RELEVANT PATIENT COMORBIDITIES OR EXISTING MEDICATIONS. ADDITIONALLY, NO INFORMATION WAS PROVIDED REGARDING THE PROCEDURAL DETAILS OR FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE. THERE WAS NO INFORMATION PROVIDED REGARDING THE MYNX PROCEDURE OR ITS USE PRE THE INSTRUCTIONS FOR USE. ADDITIONALLY, HEMATOMA IS AN ANTICIPATED COMPLICATION OF CATHETERIZATION PROCEDURES, REGARDLESS OF THE USE OF CLOSURE DEVICES. THEY CAN ALSO OCCUR WITH MANUAL COMPRESSION. 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 UNDERWENT CAROTID STENTING ON (B)(6) 2010. THE PHYSICIAN CHOSE TO USE THE MYNX FOR FEMORAL ARTERY CLOSURE FOLLOWING THE PROCEDURE. THERE WAS NO INFORMATION PROVIDED REGARDING A FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE, OR ANY INFORMATION PERTAINING TO THE STEPS PERFORMED IN THE DEPLOYMENT OF THE MYNX DEVICE. THE PATIENT'S ACT WAS 244. REPORTEDLY, THERE WAS NO COMPLICATION WITH THE MYNX PROCEDURE AND CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2010. SIX DAYS LATER, ON (B)(6) 2010, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH DRAINAGE, PAIN, AND A HEMATOMA. UPON ADMISSION, THE PATIENT HAD AN ELEVATED WHITE BLOOD CELL COUNT OF 12.6, AN INDICATION OF A POSSIBLE INFECTION. THE PATIENT WAS PUT ON VANCOMYCIN INTRAVENOUSLY. THE PATIENT WAS AMBULATED AND SUBSEQUENTLY DISCHARGED ON (B)(6) 2010 WITH NO FURTHER 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. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention