BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2880271 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08176
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    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. THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MILDLY TORTUOUS, HEAVILY CALCIFIED, DE NOVO, CONCENTRIC, 90% STENOSED, DISTAL, RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE, WITH PRE-DILATATION, A NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND WITH THE FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE NC TREK BDC WAS REMOVED, ANOTHER UNSPECIFIED 3.0MM BDC WAS USED FOR SUCCESSFUL PRE-DILATATION, AND AN UNSPECIFIED STENT WAS IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2012461

    Patients

    Seq Age Sex Outcome Treatment
    1