BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 8883520 · Received August 12, 2019

    Report

    Report Number
    3008452825-2019-00405
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DRF
    UDI-DI
    05414734304146
    PMA / PMN Number
    K961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DISSECTION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE: 3008452825-2019-00404, 3008452825-2019-00407, 2182269-2019-00113. DURING AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER ABLATION PROCEDURE A DISSECTION OCCURRED. DURING THE PROCEDURE, AS THE PHYSICIAN WAS GUIDING THE DEVICES THROUGH A NARROW LEFT ILIAC VEIN, THE PATIENT BECAME HYPOTENSIVE. A HEMOGLOBIN TEST WAS RUN AND IT WAS DETERMINED THE PATIENT NEEDED A BLOOD TRANSFUSION. CONTRAST WAS INJECTED TO DETERMINE THE LOCATION OF THE BLEEDING AND A DISSECTION WAS FOUND. VASCULAR INTERVENTION WAS NOT REQUIRED AS THE DISSECTION CLOSED ON ITS OWN. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676206 INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, COSTA RICA LTDA IBI-81404 6940899 05414734304146

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER| LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER| VIEWFLEX¿ XTRA ICE CATHETER