BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3112480 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03047
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY, A NC TREK RX DILATATION CATHETER WAS USED TO PERFORM POST DILATATION AFTER SUCCESSFUL DEPLOYMENT OF A XIENCE XPEDITION STENT. AFTER SEVERAL BALLOON INFLATIONS, THE BALLOON WAS DEFLATED AND AN ATTEMPT WAS MADE TO PULL THE BALLOON INTO THE GUIDE CATHETER. THE BALLOON BECAME CAUGHT AT THE OPENING OF THE GUIDE CATHETER. THE PHYSICIAN RE-ADVANCED THE BALLOON OUT OF THE GUIDE CATHETER AND INFLATED THE BALLOON TO NOMINAL PRESSURE. THE BALLOON WAS THEN COMPLETELY DEFLATED. ANOTHER ATTEMPT WAS MADE TO PULL THE BALLOON INTO THE GUIDE CATHETER BUT THE BALLOON COULD NOT BE FULLY INSERTED. THE NC TREK DILATATION CATHETER, GUIDE CATHETER, AND GUIDE WIRE WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212737 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: XIENCE XPEDITION