BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY WHISPER VIEW

    MDR report key: 19049371 · Received April 5, 2024

    Report

    Report Number
    19049371
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 12, 2024
    Report Date
    March 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT IS AN ELDERLY WITH COMPLICATED MEDICAL HISTORY WHO WAS ADMITTED TO FV FOR OBSERVATION FOR COMPLAINTS OF CHEST PAIN AND SOB. EP WAS CONSULTED FOR DRUG-RESISTANT AFIB AND THE DECISION WAS MADE TO PROCEED WITH CRT-D IMPLANT WITH AVJ ABLATION. DURING THE PROCEDURE, THE ATTENDING WAS PLACING A CORONARY SINUS PACING LEAD USING AN EDS WHISPER WIRE TO GAIN ACCESS. ONCE THE LEAD WAS PLACED AND THE WIRE REMOVED, IT WAS NOTED THAT THE EDS WHISPER WIRE TIP HAD BROKEN OFF AND REMAINED IN THE CORONARY SINUS. IMAGING WAS UTILIZED TO CONFIRM RETENTION OF THE TIP. VASCULAR SURGERY WAS CONSULTED ON REMOVAL AND THE DECISION WAS MADE TO LEAVE IN PLACE AND TO SECURE WITH THE CORONARY SINUS LEAD. NO FURTHER COMPLICATIONS THROUGHOUT THE REMAINDER OF THE PROCEDURE AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79062 ACUITY WHISPER VIEW WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 4648 32380638

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female