BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 15950046 · Received December 9, 2022

    Report

    Report Number
    3005334138-2022-00670
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    December 6, 2022
    Report Date
    February 3, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    UDI-DI
    05415067028198
    PMA / PMN Number
    K172393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PERFORATION OF THE ILIAC VEIN REMAINS UNKNOWN.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERFORATION OF THE ILIAC VEIN OCCURRED WHICH REQUIRED FEMORAL STENTING TO STABILIZE THE PATIENT. DURING GROIN ACCESS, THE CORONARY SINUS CATHETER (CS) WAS ADVANCED AND THE CS WAS CANNULATED. WHEN ATTEMPTING TO ADVANCE THE HD GRID CATHETER, RESISTANCE WAS NOTED AND THE CATHETER WOULD NOT TRACK UP THE FEMORAL VEIN. MULTIPLE ATTEMPTS WERE MADE AT PASSING THE HDG UP UNTIL FREE MOVEMENT OF CATHETER WAS NOTED (VENOUS ACCESS ONLY). THE PATIENT BECAME HYPOTENSIVE AND A FEMORAL VENOGRAM REVEALED A PERFORATION. FEMORAL STENTING WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS SENT TO THE ICU FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908833 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL D-AVHD-DF16 8558183 05415067028198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention