BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 8259031 · Received January 17, 2019

    Report

    Report Number
    2024168-2019-00420
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 25, 2018
    Report Date
    January 17, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648152061
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE, GUIDE CATHETER. HYPERION 6F SAL 1.0. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 75% STENOSED, MILDLY TORTUOUS, MODERATELY CALCIFIED, CONCENTRIC, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. THE 4.0X12MM NC TREK RX BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE BALLOON WAS THEN INFLATED AT 8 ATMOSPHERES FOR 30 SECONDS WHEN THE BALLOON RUPTURED. THE NC TREK BDC WAS REMOVED, AND A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51831 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80830G2 08717648152061

    Patients

    Seq Age Sex Outcome Treatment
    1