BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2803210 · Received October 24, 2012

    Report

    Report Number
    3002648230-2012-00095
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. BIN FILES WERE RECEIVED AND DO NOT SHOW ISSUES FOR THE DATE OF CASE. BIN FILES SHOW AT LEAST 8 INJECTIONS WERE PERFORMED WITH THE CATHETER. THIS REPORT WILL BE RECORDED AND TRENDED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABOUT 1 HOUR POST CRYOABLATION PROCEDURE, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP WHILE THE PATIENT WAS IN RECOVERY. ECHO SHOWED PERICARDIAL EFFUSION THAT WAS NOT NOTICED DURING THE PROCEDURE OR AT THE END OF THE PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED AND ~500 CC DRAINED. DRAIN WAS LEFT IN PLACE FOR OBSERVATION OVERNIGHT. THE PATIENT STAYED IN THE HOSPITAL TWO DAYS WITHOUT ANY REPORTED ISSUES AND WAS RELEASED ON THE THIRD DAY ((B)(6) 2012). THIS REPORT IS FOR DEVICE 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF232

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FLEXCATH STEERABLE SHEATH 3FC12