BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 12564998 · Received October 1, 2021

    Report

    Report Number
    2024168-2021-08817
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 13, 2021
    Report Date
    November 8, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    UDI-DI
    08717648138300
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 COMPLAINT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT RETURN. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCOUNT WAS UNPACKING A BOX FOR A 2.5X20MM TREK RX DILATATION CATHETER (1012272-20, 10303G1). ONCE UNPACKED, THE DEVICE INSIDE WAS NOT FOR A TREK RX BUT RATHER AN NC TREK 2.5X15MM (1012435-15). REPORTEDLY, THERE WAS NO TAMPERING WITH THE BOX AND PRODUCT INSIDE PRIOR TO THIS DISCOVERY. THERE WAS NO PROCEDURE AND NO PATIENT INVOLVING THIS DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459974 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012272-20 10303G1 08717648138300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown