BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3143335 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03463
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE XIENCE XPEDITION DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK RX RUPTURED DURING PREDILATATION WITH LOW PRESSURES IN THE HEAVILY CALCIFIED, RIGHT CORONARY ARTERY (RCA) TARGET LESION. AN NC TREK WAS ABLE TO SUCCESSFULLY PREDILATE THE TARGET LESION. THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) CROSSED THE LESION SMOOTHLY AND THE STENT WAS DEPLOYED WITH ONE INFLATION. A COUPLE OF SECONDS WERE SPENT FOR THE SDS TO DEFLATE. NEUTRAL PRESSURE WAS APPLIED TO THE SDS AND THE SDS WAS PULLED INTO THE GUIDE CATHETER. SLIGHT RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE SDS, A MINIMAL LEVEL OF FORCE WAS APPLIED, AND THE SHAFT SEPARATED IN THE GUIDE CATHETER. THE SEPARATED SEGMENT OF THE SDS WAS REMOVED WITH THE GUIDE CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244233 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: 6 FRENCH