BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE

    MDR report key: 9927846 · Received April 6, 2020

    Report

    Report Number
    2017865-2020-04661
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 6, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED THAT NO INTERVENTION REQUIRED, HOWEVER CORONARY SINUS CANUATION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE GUIDEWIRE DISSECTED THE PATIENT'S CORONARY SINUS. THERE WAS NO LEAD MOUNTED ON THE GUIDEWIRE WHEN DISSECTION OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT EMERGENCY INTERVENTION. THE PATIENT WAS WELL POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE GUIDEWIRE DISSECTED THE PATIENT'S CORONARY SINUS. THERE WAS NO LEAD MOUNTED ON THE GUIDEWIRE WHEN DISSECTION OCCURRED. THE PROCEDURE WAS COMPLETED AFTER CANULATION OF THE CORONARY SINUS. THE PATIENT WAS WELL POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392051 GUIDEWIRE NDQ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GUIDEWIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other