BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4093825 · Received September 16, 2014

    Report

    Report Number
    2024168-2014-05962
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ABOVE RATED BURST PRESSURE (RBP). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY AND POOR REFOLD WAS NOT CONFIRMED; HOWEVER IT MAY HAVE BEEN DUE TO THE CIRCUMSTANCES OF THE PROCEDURE. 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO REMOVE FROM THE GUIDING CATHETER, IMPROPER METHOD, OR POOR REFOLD REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES THAT THE BALLOON PRESSURE SHOULD NOT EXCEED THE RBP. IT IS UNKNOWN IF THE REPORTED IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TREATING A MODERATELY CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. DURING POST-DILATATION, THE 4.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 22 ATMOSPHERES. THE BALLOON WAS DEFLATED; HOWEVER, WAS NOTED TO HAVE A BAD RE-FOLD AND EXPERIENCED RESISTANCE RETRACTING INTO THE 6F GUIDING CATHETER. THE BALLOON WAS INFLATED AGAIN SLIGHTLY AND THEN DEFLATED IN AN ATTEMPT TO OBTAIN A BETTER RE-FOLD, BUT THE BALLOON STILL HAD A BAD RE-FOLD. THE BALLOON WAS ABLE TO BE RETRACTED ABOUT 80% INTO THE GUIDING CATHETER. DUE TO THE RESISTANCE WITH THE GUIDING CATHETER DURING RETRACTION, THE GUIDING CATHETER, BALLOON, AND GUIDE WIRE WERE ALL REMOVED TOGETHER AS A SINGLE UNIT. POST-DILATATION WAS CONFIRMED TO BE SUCCESSFUL AND NOTHING FURTHER NEEDED TO BE DONE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571350 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31212G1

    Patients

    Seq Age Sex Outcome Treatment
    1