BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 8595220 · Received May 9, 2019

    Report

    Report Number
    2024168-2019-03692
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 14, 2019
    Report Date
    June 17, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER (B)(4). UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT SHOULD BE NOTED THAT THE CORONARY DILATATION CATHETERS (CDC), TREK RX AND MINI TREK RX, GLOBAL, INFORMATION FOR USE, STATES: PRIOR TO ANGIOPLASTY, THE DILATATION CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND ENSURE THAT ITS SIZE IS SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE INVESTIGATION DETERMINED THE REPORTED DEVICE MARKING ISSUE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL NC TREK DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN NC TREK AND A TREK BALLOON DILATATION CATHETER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, IT WAS NOTED THAT THE BALLOON DILATATION CATHETERS DID NOT HAVE THE SIZE STAMPED ON THE DEVICES. THE SIZE STAMP WAS COMPLETELY MISSING FROM THE HUB OF BOTH BALLOON DILATATION CATHETERS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390961 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1