BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2842847 · Received November 21, 2012

    Report

    Report Number
    9673241-2012-00338
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4). THE PHYSICIAN THEN REPOSITIONED THE CATHETER A LITTLE MORE SUPERIOR FROM THE FIRST LESION AND A SECOND LESION WAS PERFORMED. DURING THE SECOND LESION, THERE WERE ECG CHANGES NOTED AND THE ABLATION WAS TERMINATED. THE PATIENT DEVELOPED LBB WITH ST ELEVATION BRADYCARDIA AND VENTRICULAR FIBRILLATION. PCI FOR OCCLUSION OF LEFT MAIN CORONARY ARTERY WITH BALLOON AND STENTING WITH IABP SUPPORT WAS PERFORMED. THE EVENT WAS NOT ATTRIBUTED TO A TRANSSEPTAL PUNCTURE. THE PHYSICIAN DID NOT KNOW WHICH CATHETER CAUSED THE EFFUSION AS HE ALSO HAD A RIGHT VENTRICLE CATHETER IN AS WELL. THE PHYSICIAN HAD A DIFFICULT TIME ACCESSING THE CORONARY SINUS OS BUT ONCE INSIDE, THE CATHETER WAS EASILY ADVANCED INSIDE THE CORONARY SINUS. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. THE RF GENERATOR WAS SET TO "POWER-CONTROL" MODE AT 35W. THE TEMPERATURE CUT-OFF SETTING WAS UNKNOWN. THE FLOW SETTING WAS SET TO 17W. A LONG SHEATH WAS NOT USED. THE PATIENT RECEIVED ANTICOAGULATION IN THE PROCEDURE. THE ACT MAINTAINED DURING THE PROCEDURE WAS UNKNOWN DURING ABLATION. WHEN THE EFFUSION OCCURRED PATIENT HAD NOT RECEIVED ANTI-COAGULATION. THE PATIENTS UPDATED HEALTH STATUS IS THAT THE PATIENT HAS BEEN EXTUBATED AND IS NEUROLOGICALLY INTACT WITH AN EF OF 50%.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT WHILE PERFORMING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, A PERICARDIAL EFFUSION WAS SUSPECTED AS THE PATIENT COMPLAINED ABOUT CHEST PAIN. THE PERICARDIAL EFFUSION WAS CONFIRMED BY FLUOROSCOPY. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED. AFTER THE PERICARDIOCENTESIS, THE PATIENT WAS THOUGHT TO BE STABLE ENOUGH TO RESUME THE CASE. THE CASE WAS RESUMED AND DURING THE SECOND ABLATION, CHANGES WERE NOTED ON THE ECG OF THE CARTO XP SYSTEM AND PRUCKA RECORDING SYSTEM. A LEFT VEIN CORONARY ARTERY OCCLUSION WAS NOTICED AS THE PATIENT BECAME BRADYCARDIC AND THE BLOOD PRESSURE DROPPED. CPR WAS PERFORMED ON THE PATIENT AND A STENT WAS PLACED IN THE LEFT VEIN. THE PATIENT WAS PUT IN ICU IN CRITICAL CONDITION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY. IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED. NO OCCLUSION WAS OBSERVED. A COOL FLOW PUMP TEST WAS PERFORMED AND THE CATHETER PASSED SPECIFICATIONS. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. SINCE THE CATHETER PASSED SPECIFICATIONS, THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, A PERICARDIAL EFFUSION WAS SUSPECTED AS THE PATIENT COMPLAINED ABOUT CHEST PAIN. THE PERICARDIAL EFFUSION WAS CONFIRMED BY FLUOROSCOPY. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED. AFTER THE PERICARDIOCENTESIS, THE PATIENT WAS THOUGHT TO BE STABLE ENOUGH TO RESUME THE CASE. THE CASE WAS RESUMED AND DURING THE SECOND ABLATION, CHANGES WERE NOTED ON THE ECG OF THE CARTO XP SYSTEM AND PRUCKA RECORDING SYSTEM. A LEFT VEIN CORONARY ARTERY OCCLUSION WAS NOTICED AS THE PATIENT BECAME BRADYCARDIC AND THE BLOOD PRESSURE DROPPED. CPR WAS PERFORMED ON THE PATIENT AND A STENT WAS PLACED IN THE LEFT VEIN. THE PATIENT WAS PUT IN ICU IN CRITICAL CONDITION. UPON REQUEST, ADDITIONAL INFORMATION WAS RECEIVED FROM THE BWI FIELD REPRESENTATIVE ON THE EVENT. AFTER PLACING A ST. JUDE MEDICAL JSN CATHETER IN THE RIGHT VENTRICLE APEX AND THE THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER IN THE CORONARY SINUS, THE PATIENT STARTED C/O CHEST PAIN AT WHICH TIME THE PHYSICIAN X-RAYED THE CHEST AND THE EFFUSION WAS NOTED. AFTER MONITORING THE PATIENT WITH TRANSTHORACIC ECHO, THE PHYSICIAN DECIDED TO PERFORM A PERICARDIALCENTESIS. AFTER EVACUATING THE PERICARDIUM, THE PHYSICIAN DECIDED TO MOVE FORWARD WITH THE PROCEDURE OF MAPPING THE PVC FROM THE LEFT VENTRICLE. OCCLUSION OF THE LEFT MAIN- AFTER ACTIVATION MAPPING IN THE LEFT VENTRICLE FOR THE PVC THAT PHYSICIAN DECIDED TO MAP IN THE CORONARY CUSP TO SEE IF ANYTHING WAS EARLIER THAN THE LEFT VENTRICLE MAP. WHILE MAPPING, THE PHYSICIAN DECIDED TO ATTEMPT ABLATION IN THE LCC. HOWEVER, THE PVC DID NOT GO AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1318-03-S 15635755L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R