BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3100507 · Received May 8, 2013

    Report

    Report Number
    2024168-2013-02880
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    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 DURING A PROCEDURE TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH 100% STENOSIS, AN UNSPECIFIED STENT WAS IMPLANTED. A 4.5X12 NC TREK RX DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE AND INFLATED FOR POST DILATATION WITHOUT ISSUE. REPORTEDLY, THE BALLOON WAS COMPLETELY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE DILATATION CATHETER FROM THE PATIENT ANATOMY. DURING WITHDRAWAL, THE 4.5X12 NC TREK RX DILATATION CATHETER WAS WITHDRAWN FROM THE PROXIMAL PORTION OF THE STENT; HOWEVER, STRONG RESISTANCE WAS THEN FELT AND THE DILATATION CATHETER BECAME STUCK INSIDE OF THE GUIDING CATHETER. THE DILATATION CATHETER, GUIDE CATHETER AND GUIDE WIRE WERE WITHDRAWN FROM THE PATIENT AS A SINGLE UNIT. THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201460 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 3011761

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR