BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6205958 · Received December 27, 2016

    Report

    Report Number
    3002648230-2016-00536
    Event Type
    Death
    Date Received
    December 27, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, FOLLOWING THE FIRST TWO ABLATIONS, THE PHYSICIAN OBSERVED POTENTIALS IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND ATTEMPTED A THIRD ABLATION. THE PATIENT'S BLOOD PRESSURE DROPPED AND CARDIAC TAMPONADE WAS OBSERVED. THE PATIENT RECEIVED EMERGENCY TREATMENT BUT THE BLOOD PRESSURE CONTINUED TO DROP. THE PATIENT THEN RECEIVED OPEN HEART SURGERY AND WAS IN STABLE CONDITION AFTER THE SURGERY. IT WAS SUBSEQUENTLY REPORTED THAT THE FOLLOWING DAY THE PATIENT DIED. THE EVENT WAS CONSIDERED TO BE DUE TO "OPERATOR'S PROBLEM" AND NOT TO ANY PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856714 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 29728

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| L| R