BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3944022 · Received July 18, 2014

    Report

    Report Number
    2024168-2014-04624
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. 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 THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED, DISTAL RIGHT CORONARY ARTERY. AFTER INTRAVASCULAR ULTRASOUND WAS PERFORMED, THE 2.5X15 MM TREK RX WAS BEING USED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THERE WAS NO RESISTANCE REPORTED DURING ADVANCEMENT OR RETRACTION OF THE BALLOON CATHETER FROM THE PATIENT. AFTER RETRACTION OF THE BALLOON CATHETER FROM THE ANATOMY A ROTABLATOR WAS USED, AFTER WHICH A XIENCE XPEDITION STENT WAS IMPLANTED IN THE LESION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422984 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40410G3

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR