BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 10468995 · Received August 28, 2020

    Report

    Report Number
    2024168-2020-07226
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 28, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648151583
    PMA / PMN Number
    K103153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED TWO OTHER SIMILAR INCIDENTS FROM THIS LOT BOTH RELATED TO THE SAME REPORTED EVENT. THE COMPLAINT INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES ARE RELATED TO A POTENTIAL LABELING/PACKAGING ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 1.50X8MM NC TREK BALLOON (1012444-08 / 71117G1) WAS RETURNED UNUSED FROM THE HOSPITAL. THE ADDENDUM LABEL CONTENT [1012448-08] WAS DISCREPANT FROM THE ORIGINAL LABEL CONTENT [1012444-08]. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932759 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012444-08 71117G1 08717648151583

    Patients

    Seq Age Sex Outcome Treatment
    1