BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4240831 · Received November 10, 2014

    Report

    Report Number
    2024168-2014-07305
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE 3.5X12MM NC TREK REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY POSITIONING THE GUIDE WIRE WAS CONFIRMED. 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    A PRODUCT FAILURE WAS REPORTED FOR A 3.5X12MM NC TREK AND A 3.5X15MM NC TREK. REPORTEDLY, ONE COULD NOT BE ADVANCED OVER AN UNSPECIFIED GUIDE WIRE, AND THE OTHER THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE; HOWEVER, IT WAS NOT REPORTED AS TO WHICH TREK HAD WHICH MALFUNCTION MODE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE 3.5X15MM NC TREK WAS RETURNED WITH THE BALLOON PEELED AND THE INNER MEMBER COLLAPSED, CONSISTENT WITH GUIDE WIRE DIFFICULTY. THE 3.5X12MM NC TREK WAS RETURNED WITH THE DISTAL SHAFT STRETCHED AND SEPARATED, CONSISTENT WITH PROTECTIVE SHEATH REMOVAL DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722209 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40709G1

    Patients

    Seq Age Sex Outcome Treatment
    1