BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1933514 · Received December 20, 2010

    Report

    Report Number
    3004939290-2010-00138
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED IN 4 SEPARATE PIECES. THE CONDITION OF THE RETURNED DEVICE AS RECEIVED EXHIBITED A CATHETER LUMEN THAT WAS CUT NEAR THE CATHETER HANDLE. VISUAL INSPECTION REVEALED THAT THE BALLOON WAS DETACHED AND THE BALLOON DISTAL TIP WAS INVERTED AND BUNCHED UP. THE PROXIMAL BALLOON BOND WAS ALSO SEVERELY DAMAGED. THE ADHESIVE TAPER HAD BROKEN OFF FROM THE POLYIMIDE SHAFT. THE PROCEDURE SHEATH AND THE ADVANCER TUBE BOTH HAD DISTAL DAMAGE. THE ADVANCER TUBE WAS BROKEN AT THE FUSED JOINT. DUE TO THE DISSECTED AND SEPARATE DEVICE COMPONENTS, THE CAUSE OF FAILURE COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED DIFFICULTY TO DEFLATE BALLOON 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

    THE ACI SALES PROFESSIONAL REPORTED THAT ON (B)(6) 2010, A(B)(6) FEMALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERY CLOSURE. NO INFORMATION WAS PROVIDED REGARDING A FEMORAL ANGIOGRAM TO ASSESS SUITABILITY FOR CLOSURE. THE DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT DURING THE CLOSURE PROCEDURE, THE PHYSICIAN COULD NOT DEFLATE THE BALLOON AND THEREFORE WAS UNABLE TO REMOVE THE DEVICE. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) WHERE IT WAS REPORTED THAT THE CATHETER HAD BEEN LEFT IN SITU AT THE RIGHT GROIN. AN INCISION WAS MADE OVER THE RIGHT COMMON FEMORAL ARTERY (CFA) AND WITH A BLUNT AND SHARP DISSECTION, THE FEMORAL ARTERY WAS IDENTIFIED. THE PHYSICIAN WAS ABLE TO FEEL THE BALLOON INSIDE THE ARTERY AT THIS POINT. IT WAS DECIDED TO PUNCTURE THE BALLOON FROM OUTSIDE OF THE ARTERY. ONCE THE BALLOON WAS PUNCTURED AND ASPIRATED, THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE. THE PUNCTURE WAS THEN REPAIRED WITH 5-0 PROLENE. THE WOUND WAS CLOSED WITH 2 LAYERS AND THE SKIN WAS APPROXIMATED WITH A SUBCUTICULAR STITCH. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS RETURNED TO THE RECOVERY ROOM REPORTEDLY IN GOOD CONDITION. THE PATIENT WAS DISCHARGED LATER THAT SAME DAY. 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. MX6700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention