BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3213853 · Received July 9, 2013

    Report

    Report Number
    9673241-2013-00224
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4). ON (B)(6) 2013, THE PATIENT HAD AN ADULT ECHO. THE LEFT ATRIUM WAS MILDLY DILATED. THE LEFT VENTRICLE WAS NORMAL IN SIZE, WALL THICKNESS AND SYSTOLIC FUNCTION. THE EJECTION FRACTION WAS 60% TO 65%. THE RIGHT VENTRICLE APPEARED DILATED. THE RIGHT VENTRICULAR FREE WALL APPEARED TO BE SOMEWHAT HYPOKINETIC. THERE WAS A SMALL ECHO SPACE NEAR THE RIGHT VENTRICULAR APEX, PROBABLY AN OLD PERICARDIAL EFFUSION. THERE WAS NO EVIDENCE OF TAMPONADE PHYSIOLOGY. ON (B)(6) 2013, THE PATIENT HAD AN ADULT ECHO. THE LEFT ATRIUM WAS MILDLY DILATED. THE LEFT VENTRICLE WAS NORMAL IN SIZE, NORMAL WALL MOTION AND SYSTOLIC FUNCTION. THE EJECTION FRACTION WAS ABOUT 60%. THE RIGHT ATRIUM APPEARED DILATED. THE RIGHT VENTRICLE APPEARED NORMAL IN SIZE AND SYSTOLIC FUNCTION. FREE WALL OF RIGHT VENTRICLE WAS NOT CLEARLY VISUALIZED. THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION OR TAMPONADE PHYSIOLOGY. ON (B)(6) 2013, THE PATIENT HAD AN ECHOCARDIOGRAM. THE LEFT ATRIUM WAS MILDLY DILATED. THE LEFT VENTRICLE WAS NORMAL IN SIZE. THE EJECTION FRACTION WAS 60%.THE RIGHT VENTRICLE APPEARED NORMAL IN SIZE, WALL THICKNESS AND SYSTOLIC FUNCTION. THE RIGHT VENTRICULAR FUNCTION WAS NORMAL. THERE WAS NO EVIDENCE OF INTRACARDIAC MASS, THROMBUS OR VEGETATION. THERE WAS A VERY SMALL PERICARDIAL EFFUSION. NO TAMPONADE PHYSIOLOGY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ON THE EVENT WAS PROVIDED ON (B)(4) 2013 BY THE BWI FIELD REPRESENTATIVE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION WAS THAT THE CATHETER INDUCED A PERFORATION OF THE LEFT ATRIUM. THE OTHER FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE PERFORATION WAS THE PATIENT¿S DIFFICULT ANATOMY WITH A LARGE RIDGE CARDINA. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. THERE WERE ABOUT 9 ABLATION APPLICATIONS DELIVERED TO THE PATIENT BEFORE THE EVENT. THE RF GENERATOR WAS SET TO ¿POWER-CONTROL¿ MODE AT 35 WATTS. THE FLOW SETTING WAS SET TO 17CC. THE SHEATH USED WAS THE AGILIS. THE ACT MAINTAINED DURING THE PROCEDURE WAS 300-350.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) / ATRIAL FLUTTER (AFL) PROCEDURE, THE PATIENT HAD A TAMPONADE AND PERICARDIAL EFFUSION. ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THEY WERE ABLE TO FINISH ABOUT 25% OF THE ABLATION BEFORE THE PATIENT WAS COMPLICATED BY A PERICARDIAL TAMPONADE AND EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS STATUS POST PERICARDIAL CATHETER INSERTION. THERE WAS 250 CC OF SANGUINEOUS DRAINAGE. INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIUM SHOWED ALMOST COMPLETE RESOLUTION OF THE PERICARDIAL EFFUSION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND HE WAS IN STABLE CONDITION. THE PATIENT WOKE UP BRIEFLY AND RESPONDED APPROPRIATELY. THE PATIENT DENIED ANY SHORTNESS OF BREATH OR CHEST PAIN. THE PATIENTS¿ BLOOD PRESSURE WAS 134/73 AND A PULSE OF 63. THE PERICARDIAL CATHETER WAS REMOVED AND THE PATIENT TOLERATED WELL. ON (B)(6) 2013, THE PATIENT DEVELOPED URINARY RETENTION AND HAD A HISTORY OF BPH. A FOLEY CATHETER WAS INSERTED. THE PATIENT WAS STARTED ON TAMSULOSIN 0.4 MG AND FINASTERIDE 5 MG P.O. DAILY. THE PATIENT TOLERATED THE MEDICATION WELL WITHOUT ANY SIDE EFFECTS FROM THE MEDICATIONS. SUBSEQUENTLY IV CARDIZEM WAS STARTED AND HE WAS PUT ON RYTHMOL 300 MG P.O. DAILY. HIS HEART RATE WAS WELL CONTROLLED AND IV CARDIZEM WAS STOPPED. IT WAS RECOMMENDED TO PERFORM AN EXTERNAL CARDIOVERSION, BUT THE PATIENT DECLINED AND WANTED TO GO HOME. ON (B)(6) 2013, THE PATIENT WAS IN STABLE CONDITION. IT WAS FELT THAT HE REACHED MAXIMUM HOSPITAL BENEFIT AND WAS APPROPRIATE FOR DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313050 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-00 UNKNOWN_TCOOL SF C3

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R