BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4233667 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07283
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SEPARATION WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN UNSPECIFIED CORONARY ARTERY, WHEN ADVANCING A 3.5X12 NC TREK RX DILATATION CATHETER THROUGH THE GUIDING CATHETER THERE WAS A SLIGHT ANGLE ON IT AND THE HYPOTUBE SEPARATED INTO TWO PIECES OUTSIDE OF THE PATIENT ANATOMY. REPORTEDLY, THERE WAS NO RESISTANCE DURING ADVANCEMENT OR WITHDRAWAL OF THE DILATATION CATHETER. ADDITIONALLY, NO RESISTANCE WAS FELT WHEN THE DEVICE WAS REMOVED FROM THE DISPENSER HOOP PRIOR TO USE. THE SEPARATED PORTION OF THE NC TREK DILATATION CATHETER WAS SIMPLY WITHDRAWN AND A NEW SAME SIZE NC TREK RX WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO 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
    714434 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40516G1

    Patients

    Seq Age Sex Outcome Treatment
    1