BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 6707636 · Received July 12, 2017

    Report

    Report Number
    3002648230-2017-00332
    Event Type
    Death
    Date Received
    July 12, 2017
    Date of Event
    March 25, 2014
    Report Date
    July 28, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: ATRIOESOPHAGEAL FISTULA COMPLICATING CRYOBALLOON PULMONARY VEIN ISOLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. CIRCULATION: ARRHYTHMIA AND ELECTROPHYSIOLOGY. 2014;25(7): 787-792.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT RECEIVED ABLATIONS TO THE RIGHT AND LEFT PULMONARY VEINS (PV). IT WAS NOTED THAT THE ESOPHAGEAL TEMPERATURE WAS MONITORED BY A COMPETITOR PROBE. THE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST DISCOMFORT THAT WAS RESOLVED WITH MEDICATION. THE PATIENT WAS DISCHARGED WITH THE NORMAL MEDICATION PROTOCOLS, IN ADDITION TO MEDICATION FOR A PRESUMED PERICARDITIS. THREE DAYS LATER, THE PATIENT DEVELOPED FEVERS, CHILLS AND MID ABDOMINAL PAIN THAT WERE CONSIDERED EPISODIC BUT NOW OCCURRED MULTIPLE TIMES PER DAY AND WERE ACCOMPANIED BY SEVERE RIGORS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND A COMPUTERIZED TOMOGRAPHY (CT) WERE PERFORMED AND A THROMBUS AT THE LEFT INFERIOR PULMONARY VEIN (PV) WAS OBSERVED. THE PATIENT'S ESOPHAGUS WAS NORMAL WITH NO EVIDENCE OF MUCOSAL THICKENING OR INTRAMURAL AIR. THE PATIENT WAS DIAGNOSED WITH AN INFECTED THROMBUS. THE FOLLOWING DAY, THE PATIENT COLLAPSED AND WAS FOUND TO BE IN VENTRICULAR FIBRILLATION (VF). CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ANOTHER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND IT WAS CONFIRMED THAT THE THROMBUS WAS NO LONGER PRESENT. IT WAS NOTED THAT A DISTAL EMBOLI WAS OBSERVED IN THE LEFT ANTERIOR CORONARY ARTERY. IT WAS PRESUMED THAT THE EMBOLUS HAD BROKEN UP DURING CPR AND ECMO PLACEMENT. A CT SCAN WAS PERFORMED AND GLOBAL EDEMA WITH EARLY HERNIATION WAS OBSERVED. THE DECISION WAS MADE TO WITHDRAW SUPPORT AND THE PATIENT LATER EXPIRED. AN AUTOPSY WAS PERFORMED AND A "DIME SIZED EROSION" ON THE ANTERIOR ESOPHAGEAL WALL WITH AN ADHESION ON THE POSTERIOR SURFACE OF THE LEFT ATRIUM. A DIAGNOSIS OF AN ATRIAL ESOPHAGEAL FISTULA WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485750 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF282 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 DA Death| H| L| R