BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4553373 · Received February 27, 2015

    Report

    Report Number
    2024168-2015-01051
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 3, 2015
    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. CONCOMITANT PRODUCTS: GUIDE WIRE: SION, RUNTHROUGH HC, GUIDE CATH: LAUNCHER 7F. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BALLOON RUPTURE WAS CONFIRMED. THE REPORTED RESISTANCE DURING ADVANCEMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CONCENTRIC, HEAVILY CALCIFIED, NON-TORTUOUS, 90% STENOSED, DE NOVO, MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION WITH A VESSEL DIAMETER OF 2.5 MM AND LESION LENGTH OF 5 MM, NON-ABBOTT GUIDE WIRES WERE POSITIONED IN THE DISTAL LAD AND PAST THE BIFURCATION AREA OF THE PROXIMAL LAD AND MID LAD. A 2.0 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ACROSS THE LESION WITH SOME ANATOMICAL RESISTANCE AND INFLATED; HOWEVER, THE BALLOON RUPTURED AT 16 ATMOSPHERE (ATM). THE BDC WAS REMOVED AND REPLACED WITH A NON-ABBOTT BDC AND PRE-DILATATION WAS PERFORMED. AFTER INTRAVASCULAR ULTRASOUND (IVUS) A 2.5 X 8 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE LESION AND THE PROCEDURE WAS COMPLETED AFTER POST-DILATATION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138462 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40121G1

    Patients

    Seq Age Sex Outcome Treatment
    1