BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3083321 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02671
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED, 99% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE 2.0X15 MM NC TREK BALLOON CATHETER WAS USED FOR PRE-DILATATION; HOWEVER, DURING SECOND INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES. A SECOND NC BALLOON WAS USED AND A STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO RESISTANCE WAS FELT DURING ADVANCEMENT OR RETRACTION OF THE DEVICE. THE PHYSICIAN NOTED THE RUPTURE BY CONFIRMING BLOOD BACKFLOW TOWARD THE INDEFLATOR. 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
    185493 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1113061

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION BLUEGUIDE CATH: PROFIT 6F