BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2003720 · Received February 23, 2011

    Report

    Report Number
    3002648230-2011-00005
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PERICARDIAL EFFUSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CARDIAC CRYOABLATION PROCEDURES AND IS NOT NECESSARILY LINKED TO A KINK IN THE FLEXCATH SHEATH. EVALUATION OF THE DEVICES IS ONGOING AND RESULTS WIL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED USING THE ARCTIC FRONT CATHETER. ALL SHEATH AND CATHETERS PLACED WITHOUT APPARENT INCIDENT. ALL FOUR VEINS VIEWED BOTH WITH A CIRCULAR MAPPING CATHETER AND WITH CONTRAST INJECTION VIA A MP CATHETER PLACED THROUGH THE FLEXCATH SHEATH. BOTH LEFT SIDED VEINS WERE ABLATED WITH THREE 4 MINUTE LESIONS EACH. AT THIS POINT, A CIRCULAR MAPPING CATHETER WAS PLACED IN THE SVC ABOVE THE LEVEL OF THE RSPV AND CAPTURE OF THE RIGHT DIAPHRAGM OBTAINED. THEN THE RIGHT INFERIOR PULMONARY VEIN WAS ABLATED WITH ONE FOUR MINUTE LESION. DURING POSITIONING FOR THE SECOND LESION IN THE RIPV, IT WAS NOTED THAT THE PRESSURE HAD BEEN SLOWLY DECREASING. THE PROCEDURE WAS STOPPED AND AN ECHO WAS DONE. THE PT WAS FOUND TO HAVE A PERICARDIAL EFFUSION. A PERICARDIAL TAP WAS PERFORMED AND 480CC OF FLUID WAS DRAINED. THE PT WAS DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. UPON REMOVAL OF THE ARCTIC FRONT CATHETER AND THE FLEXCATH SHEATH, THE SHEATH WAS FOUND TO BE KINKED. THERE WAS NO DEFECT REPORTED FOR THE ARCTIC FRONT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP 2AF232 06812-09

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability LOT # 15438-81, EXPIRATION DATE: 2012-11| FLEXCATH STEERABLE SHEATH, MODEL # 3FC12