BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3953540 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04718
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULT TO REMOVE WITH THE GUIDING CATHETER WAS NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS AND CINE REVIEW OF THE RETURNED DEVICE, WHICH WAS UNABLE TO CONFIRM THE ISSUE, 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 ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO REMOVE WITH THE GUIDING CATHETER REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY. AFTER SUCCESSFULLY USING THE 3.5X15 MM NC TREK BALLOON CATHETER FOR POST-DILATATION OF A DEPLOYED STENT, AND AFTER FULL DEFLATION OF THE BALLOON WITHOUT ISSUE, THE BALLOON CATHETER COULD NOT BE RETRACTED INTO THE GUIDING CATHETER. NEUTRAL PRESSURE WAS APPLIED TO THE BALLOON WITH A 20CC SYRINGE, BUT WITHOUT SUCCESS. THE GUIDING CATHETER AND THE BALLOON CATHETER WERE REMOVED TOGETHER AS ONE UNIT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430597 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30520G1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR GUIDE CATH: 6F