BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOPATH TRANSFEMORAL ACCESS SYSTEM

    MDR report key: 3835848 · Received May 13, 2014

    Report

    Report Number
    3004672932-2014-00005
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ONSET MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K100819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE SOLOPATH BROKE DURING A AAA AND FEM FEM PROCEDURE. FOLLOW-UP COMMUNICATION CONFIRMED THAT: THE ILIAC WAS TORTUOUS AND SMALL; THE SOLOPATH ADVANCED GREAT; WHEN IT WAS TIME TO LAY THE GORE GRAPHS THE ILIAC SPASMED AND THE SOLOPATH BECAME STUCK; AN ATTEMPT TO PULL BACK THE SOLOPATH SHEATH WAS UNSUCCESSFUL; AN ATTEMPT TO TURN THE SOLOPATH, RE-INFLATED THE DEVICE AND THEN DEFLATED IT AND REMOVED THE BALLOON, STILL NO SUCCESS; ANOTHER ATTEMPT TO TURN THE SOLOPATH 1/2 TURN AND PULL BACK WAS WITHOUT SUCCESS; THE PHYSICIAN THEN INTRODUCED AN OCCLUSION BALLOON INTO THE ILIAC TO GET THE SOLOPATH OUT; THE PHYSICIAN PUT THE BALLOON UP AND PULLED VERY HARD; DURING THE ATTEMPT TO PULL THE SOLOPATH BROKE IN HALF; THE PHYSICIAN HAD TO CONTROL THE BLEEDING AND GO IN AND RETRIEVE THE PORTION OF THE SOLOPATH IN THE ILIAC; PHYSICIAN HAD TO REPAIR THE DAMAGED ILIAC; AND PATIENT IS REPORTED "RECOVERED AND RETURNED HOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285378 SOLOPATH TRANSFEMORAL ACCESS SYSTEM INTRODUCER DYB ONSET MEDICAL CORPORATION NA W036484

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention BALLOONS| GORE STENTS