BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED

    MDR report key: 10988273 · Received December 10, 2020

    Report

    Report Number
    3005334138-2020-00589
    Event Type
    Death
    Date Received
    December 10, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ST. JUDE MEDICAL (AFD-PLYMOUTH)
    Product Code
    DRF
    UDI-DI
    05415067028198
    PMA / PMN Number
    K172393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 0

    RELATED MFR NUMBER: 3005334138-2020-00581.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    DURING THE VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE PATIENT HAD A CARDIAC PERFORATION AND SUBSEQUENTLY DIED. AN HD GRID WAS INSERTED THROUGH A SL1 INTRODUCER. A TRANSSEPTAL PUNCTURE WAS PERFORMED USING A NON-ABBOTT GUIDEWIRE AND THE SHEATH PASSED SUCCESSFULLY INTO WHAT WAS BELIEVED TO BE THE LEFT PULMONARY VEIN, ALTHOUGH THE LOCATION WAS NOT CERTAIN AFTER SWITCHING THE GUIDEWIRES OUT FOR THE SHEATH. RESISTANCE WAS FELT WHILE TRYING TO CROSS INTO THE MITRAL VALVE. THE SHEATH WAS RETRACTED AND ADVANCED AGAIN, AND IT WAS POSSIBLE IT PERFORATED THE LEFT ATRIAL APPENDAGE AT THIS TIME. THE HD GRID DID NOT MOVE WHERE EXPECTED, AND IT BECAME CLEAR DURING MAPPING THAT IT WAS IN THE PERICARDIAL SPACE. AN EFFUSION WAS IDENTIFIED VIA TRANSTHORACIC ECHOCARDIOGRAPHY, A PERICARDIOCENTESIS WAS PERFORMED ON THE TABLE AND THE PATIENT WAS PREPPED FOR SURGERY TO REPAIR THE PERFORATION FROM THE SHEATH. THE BLEEDING LATER STABILIZED, AND NO SURGERY WAS NEEDED. THE PATIENT DIED OVERNIGHT FROM PULSELESS ELECTRICAL ACTIVITY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446386 ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL (AFD-PLYMOUTH) D-AVHD-DF16 7553237 05415067028198

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER