BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2840819 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07340
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT SEPARATION AND KINK WERE CONFIRMED. HOWEVER, THE FAILURE TO CROSS AND DIFFICULTY TO POSITION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE, OR ATTEMPT TO STRAIGHTEN, A CATHETER IF THE SHAFT HAS BECOME BENT OR KINKED; THIS MAY RESULT IN THE SHAFT BREAKING. INSTEAD, PREPARE A NEW CATHETER. IN THIS CASE, IT IS LIKELY THAT HANDLING OF THE SHAFT IN ATTEMPT TO STRAIGHTEN CONTRIBUTED TO THE REPORTED SHAFT DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THERE WAS NO REPORT OF TORTUOSITY OR CALCIFICATION. THE 4.5 X 20 MM NC TREK BALLOON CATHETER WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION. THE BALLOON CATHETER WAS PARTIALLY REMOVED, AND THE DISTAL PORTION REMAINED IN THE GUIDING CATHETER. A BEND WAS SEEN IN THE MID SHAFT; THEREFORE, AN ATTEMPT WAS MADE TO STRAIGHTEN THE DEVICE, BUT THE SHAFT SEPARATED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND A NEW 4.5 X 20 MM NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1052561

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR