BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 4190336 · Received October 21, 2014

    Report

    Report Number
    3002648230-2014-00173
    Event Type
    Death
    Date Received
    October 21, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION OF A PATIENT DEATH. PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE DURING POSITIONING FOR THE 5TH ABLATION IN THE LEFT ATRIUM (THE 2ND ABLATION IN THE LEFT INFERIOR PULMONARY VEIN). A PERICARDIAL EFFUSION WAS SEEN ON THE INTERCARDIAC ECHOCARDIOGRAPHY. PERICARDIOCENTESIS PERFORMED TO DRAIN THE BLOOD FROM THE PERICARDIAL SAC. PATIENT'S BLOOD PRESSURE REMAINED AT 40/20 WHILE PHYSICIAN WITHDREW 1L AND 600ML OF BLOOD FROM THE PERICARDIAL SAC. IT WAS DETERMINED THAT THE PATIENT WAS STILL BLEEDING EXCESSIVELY FROM THE EFFUSION AND WAS STILL HEMODYNAMICALLY UNSTABLE. A CARDIOTHORACIC SURGEON OPENED PATIENT'S CHEST TO ACCESS THE DAMAGE AND PERFORMED OPEN CHEST CPR. THE PATIENT WAS PRONOUNCED DEAD. DEVICE 2 OF 3, REFERENCE MFR REPORT: 3002648230-2014-00172 AND 3007798852-2014-00015

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667523 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death ARCTIC FRONT ADVANCE 2AF284, ACHIEVE 990063-020