BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 8233524 · Received January 10, 2019

    Report

    Report Number
    2024168-2019-00247
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 20, 2018
    Report Date
    January 9, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648151972
    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 CATH: HYPERION 6F SAL1.0. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO ANATOMICAL CONDITIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 80% STENOSED, MODERATELY CALCIFIED LESION IN THE MILDLY TORTUOUS MID RIGHT CORONARY ARTERY. THE 3.5X12 MM NC TREK RX BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 40 SECONDS. THE NC TREK BDC WAS REMOVED WITHOUT RESISTANCE AND A NON-ABBOTT BDC WAS USED TO CONTINUE THE PROCEDURE. 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
    30120 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 81010G1 08717648151972

    Patients

    Seq Age Sex Outcome Treatment
    1