BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2841893 · Received November 21, 2012

    Report

    Report Number
    3002648230-2012-00113
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. NEITHER BIN FILES NOR FAILURE FILES SHOW ANY SYSTEM NOTICE FOR THE DATE OF CASE. BIN FILES SHOW AT LEAST (B)(4) 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

    DURING A CRYOABLATION PROCEDURE, THE PHYSICIAN THOUGHT THAT HE MAY HAVE PERFORATED THE LEFT ATRIAL APPENDAGE WITH THE GUIDEWIRE WHILE TRYING TO CANNULATE THE LSPV. HE PULLED EVERYTHING BACK AND THEN CANNULATED THE TRUE LSPV. HE INFLATED THE CRYOBALLOON, OCCLUDED, AND STARTED THE FIRST TREATMENT. DURING THIS TREATMENT, BLOOD PRESSURE STARTED TO DRIFT DOWNWARDS AND THE CRYOABLATION WAS TERMINATED AT 215 SECONDS. PATIENT HAD A PERICARDIOCENTESIS PREFORMED, PATIENT STABILIZED AND WAS PUT ON OBSERVATION. THE PATIENT WAS STABILIZED IN PROCEDURE ROOM AND THERE WAS NO NEED FOR FURTHER INTERVENTION. FOLLOW UP ON (B)(4) 2012 INDICATED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention