BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2023195 · Received March 16, 2011

    Report

    Report Number
    3002648230-2011-00014
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, MEDTRONIC COMPLETED A THOROUGH INSPECTION OF ALL MEDTRONIC PRODUCTS USED IN THE CASE INCLUDING TWO CRYOCONSOLES, A FREEZER MAX CATHETER, AN ARCTIC FRONT CATHETER AND A FLEXCATH SHEATH. WE ALSO COMPLETED SIMULATED INFLATIONS/ABLATIONS USING THE CATHETERS AND THE SHEATHS. THIS INSPECTION INDICATED THAT ALL MEDTRONIC PRODUCTS USED DURING THE CASE WERE INTACT AND OPERATING NORMALLY. WE FOUND NO ANOMALIES OR ABNORMALITIES. ADDITIONALLY, NO ERROR MESSAGES WERE RECORDED BY THE CONSOLE AS PART OF THE ARCTIC FRONT PROCEDURE. THE INFO SUBMITTED REFLECTS ALL RELEVANT DATA REC'D. IF ADD'L RELEVANT INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PT WITH ATRIAL FIBRILLATION, WAS HAVING AN EP/CATHETER ABLATION PROCEDURE WITH THE ARCTIC FRONT BALLOON SYSTEM. THE PROCEDURE WAS COMPLICATED BY A MASSIVE AMOUNT OF AIR INFUSION INTO THE LEFT SIDE OF THE HEART, SUBSEQUENTLY INTO THE AORTA AND DISSEMINATED. THIS RESULTED IN DEATH. THE PHYSICIAN HAD JUST COMPLETED APPLYING LESIONS TO THE LEFT PULMONARY VEINS, AND THE ARCTIC FRONT BALLOON AND GUIDE WIRE WERE RETRACTED BACK INTO THE FLEXCATH SHEATH. THE FLEXCATH SHEATH WAS THEN LINED UP WITH WHAT LOOKED TO BE THE RIGHT INFERIOR PULMONARY VEIN. THE PROCEDURE WAS ONGOING W/O COMPLICATIONS UP TO THIS POINT. HOWEVER, AT THIS STAGE, THE CLINICIAN NOTED AIR IN THE PT WHICH WAS QUICKLY FOLLOWED BY A SUDDEN DROP IN BLOOD PRESSURE, AND THEN BRADYCARDIA. A LARGE VOLUME OF OPACIFICATION IN THE LEFT VENTRICLE AND IN THE AORTA WAS NOTED BY FLUOROSCOPY, THEN AIR IN THE AORTA WAS VERIFIED BY CINE. THE BALLOON AT THIS STAGE WAS STILL WITHIN THE FLEXCATH SHEATH. THE HIGH PRESSURE LINE LEADING TO THE FLEXCATH WAS NOTED TO BE FULL OF AIR, THE 500 CC SALINE BAG WAS EMPTY AND THERE WAS NO OTHER OBVIOUS SOURCE FOR AIR IDENTIFIED BY THE STAFF NOR ANY EVIDENCE OF SALINE ON THE DRAPES OR THE FLOOR. THE SHEATH SYSTEMS WERE THEN QUICKLY WITHDRAWN INTO THE RIGHT SIDE OF THE HEART. THE OTHER TRANSEPTAL SHEATH (10 FRENCH SHEATH) WITH THE 8 MM CRYOCATHETER HAD NO OBVIOUS AIR AND THE HEPARINIZED SALINE LINE HAD BEEN GOING AT 75 CC/H AND WAS STILL NOTED TO HAVE SALINE WITH NO BACK-BLEEDING NOTED AND NO AIR IN THIS LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP 2AF282 07293-16

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death TWO CRYOCONSOLES| FREEZOR MAX CATHETER| FLEXCATH SHEATH