BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 17776196 · Received September 19, 2023

    Report

    Report Number
    2024168-2023-10270
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    May 25, 2023
    Report Date
    October 19, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648152085
    PMA / PMN Number
    K103153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED SEPARATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4 LOT NUMBER UPDATED FROM UNKNOWN TO 30327G1; THE PART NUMBER UPDATED FROM UNK NC TREK TO 1012453-20.

    Description of Event or Problem · 0

    A PHOTO WAS PROVIDED OF AN UNSPECIFIED NC TREK THAT APPEARS TO BE SEPARATED INTO SEPARATE PIECES. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED, IT WAS NOTED THE DEVICE WAS A 4.0X20MM NC TREK BALLOON DILATATION CATHETER THAT WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519050 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 30327G1 08717648152085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown