BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2841640 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07360
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 EVALUATION AND 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. 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. IT SHOULD BE NOTED THAT THE NC TREK INSTRUCTION FOR USE STATES: IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND / OR DAMAGE / SEPARATION OF THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 4.0X8 MM TREK BALLOON WOULD NOT CROSS THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION LOCATED IN THE RIGHT CORONARY ARTERY. FORCE WAS APPLIED DURING THE ATTEMPT TO CROSS, WHICH RESULTED IN A PROXIMAL SHAFT SEPARATION. THE ENTIRE CATHETER WAS REMOVED WITHOUT ISSUE. THE DECISION WAS MADE NOT TO PROCEED WITH THE CASE AND THE PATIENT WAS PLACED ON MEDICAL MANAGEMENT. 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
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2072861

    Patients

    Seq Age Sex Outcome Treatment
    1