BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREPATH GUIDEWIRE

    MDR report key: 6028898 · Received October 13, 2016

    Report

    Report Number
    2024168-2016-06936
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 19, 2016
    Report Date
    January 10, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY NEOMETRICS. THE DEVICE WAS RETURNED FOR ANALYSIS. A CORE BREAK WAS OBSERVED AT APPROXIMATELY 0.45" FROM THE DISTAL TIP OF THE WIRE. THE COIL WAS OBSERVED TO BE STRETCHED, BUT NOT BROKEN. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2016 WHICH DETERMINED THAT IT IS LIKELY THAT THE PHYSICIAN, WHEN ATTEMPTING TO CROSS THE CTO, DAMAGED THE GUIDE WIRE AND WHEN THE GUIDE WIRE WAS REMOVED, AGAINST RESISTANCE, IT BROKE. THIS GUIDE WIRE CONFIGURATION HAS A 0.67 LB. MINIMUM TENSILE FORCE SPECIFICATION WHICH WAS MET DURING IN-PROCESS INSPECTIONS AND WAS LIKELY SURPASSED DURING THIS PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY NEOMETRICS, INC; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE ANTERIOR TIBIAL, BELOW BIFURCATION, THAT WAS HEAVILY CALCIFIED. THE SUREPATH 300CM GUIDE WIRE WOULD NOT CROSS THE CTO. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT ANATOMY, BACK THROUGH 0.018 COMPATIBLE NON-ABBOTT SUPPORT CATHETER WITH RESISTANCE. THE TIP APPEARED KINKED, BUT THEN IT WAS NOTICED THAT THE INNER CORE WAS SEPARATED, BUT HELD TOGETHER BY THE OUTER COATING WHICH WAS RIPPED OFF DISTALLY. IT WAS CONFIRMED THAT NO DEVICE FRAGMENT STAYED BEHIND THE PATIENTS ANATOMY. THE PROCEDURE WAS COMPLETED USING A NEW SUPPORT CATHETER WITH A NON-ABBOTT GUIDE WIRE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677153 SUREPATH GUIDEWIRE GUIDE WIRE DQX AV-TEMECULA-CT M027303

    Patients

    Seq Age Sex Outcome Treatment
    1 SUPPORT CATHETER: TRAILBLAZER 0.018