BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1821444 · Received August 31, 2010

    Report

    Report Number
    3004939290-2010-00101
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON LIMITED PROCEDURAL INFORMATION AND WITHOUT RETURN OF A DEVICE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CAUSE OF THE REPORTED FAILURE COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE BALLOON WAS PULLED THROUGH THE ARTERIOTOMY WHICH COULD HAVE CONTRIBUTED TO THE HEMATOMA. HOWEVER, BASED ON THE PATIENT AND PROCEDURE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE CAUSE OF THE REPORTED BALLOON PULL THROUGH AND HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED. PER THE MYNX INSTRUCTIONS FOR USE (IFU), CONTINUE TO WITHDRAW THE BALLOON CATHETER UNTIL THE BALLOON ABUTS THE ARTERIOTOMY SITE (SECOND POINT OF TACTILE RESISTANCE). 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) FEMALE PATIENT UNDERWENT A PERIPHERAL INTERVENTION PROCEDURE ON (B)(6) 2010. 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. THE PHYSICIAN, WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERY CLOSURE FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE BALLOON PULLED BACK THROUGH THE ARTERIOTOMY AND A LARGE HEMATOMA FORMED. PRESSURE WAS HELD FOR A "LONG" DURATION AND A FEMOSTOP WAS APPLIED ONCE THEY FELT THEY HAD CONTROL OF THE BLEEDING. IT WAS REPORTED THAT THE PATIENT ACTUALLY CODED IN IVCU; HER SYSTOLIC BP DROPPED TO 50 BUT SHE WAS REVIVED. HEMOSTASIS WAS FINALLY ACHIEVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 WITH NO FURTHER CLINICAL SEQUELA AND IS REPORTEDLY DOING 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 67 YR Other