BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO TEMPORARY PACING LEAD

    MDR report key: 9225453 · Received October 23, 2019

    Report

    Report Number
    9225453
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 11, 2019
    Manufacturer
    BIOTRACE MEDICAL, INC.
    Product Code
    LDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT TAVR FOR SEVERE AORTIC STENOSIS ON (B)(6) 2019. DURING THE PROCEDURE, A 6-FR TEMPO TEMPORARY PACING WIRE WAS INSERTED AND ADVANCED INTO THE RIGHT VENTRICLE UNDER FLUOROSCOPY. THE RV TYNES WERE DEPLOYED SUCCESSFULLY. THE WIRE WAS CONNECTED TO A PACING BOX WITH A BACKUP RATE OF 40 BPM. DURING WIRE REMOVAL ON (B)(6) 2019, 1-2MM PIECE OF THE SOFT PLASTIC TIP OF THE CATHETER BROKE OFF AND IS BELIEVED TO BE RETAINED, LIKELY IN A SMALL PULMONARY VEIN AND CANNOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022236 TEMPO TEMPORARY PACING LEAD TEMPORARY PACEMAKER WIRE LDF BIOTRACE MEDICAL, INC. 31140

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other