BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3080358 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02605
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED DIFFICULTY COULD NOT BE REPLICATED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL 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. REVIEW 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 THE PROCEDURE WAS TO TREAT A NON-CALCIFIED, NON-TORTUOUS LESION LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. AFTER SUCCESSFUL POST-DILATATION OF A STENT AND FULL DEFLATION OF THE 3.5 X 8 MM NC TREK BALLOON, RESISTANCE WAS FELT DURING RETRACTION OF THE BALLOON CATHETER THROUGH THE GUIDING CATHETER. AFTER RETRACTION OF THE BALLOON CATHETER, A KINK WAS OBSERVED IN THE BALLOON AREA OF THE CATHETER. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT OF THE BALLOON CATHETER IN THE ANATOMY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181231 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30115G2

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR