BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2962696 · Received February 14, 2013

    Report

    Report Number
    3008203003-2013-00020
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WERE TWO ISSUES. FIRST ISSUE. A FORCE VECTOR OF THE SMART TOUCH BIDIRECTIONAL CATHETER WAS INDICATED IN THE OPPOSITE DIRECTION WHEN THE CATHETER CONTRACTED IN A LATERAL DIRECTION. THE PROCEDURE WAS CARRIED ON WITH THE CATHETER BECAUSE THERE WAS NO PROBLEM EXCEPT THAT ISSUE. THIS ISSUE IS PROBABLY RELATED TO CATHETER CALIBRATION, THE ROOT CAUSE IS OPERATOR'S ERROR DURING CALIBRATION, THE CATHETER CALIBRATION IS DONE WHEN THE CATHETER IS DEFLECTED IN A CERTAIN DIRECTION. SECOND ISSUE. THE PHYSICIAN CONFIRMED THE FLUOROSCOPE DURING SEQUENTIAL ABLATION OF THE POSTERIOR WALL OF THE RSPV. THEN IT WAS FOUND THAT THE SMART TOUCH BIDIRECTIONAL CATHETER PROJECTED OUT FROM THE CARDIAC OUTLINE A LITTLE. THE BLOOD PRESSURE REDUCTION WAS ALSO OBSERVED. ACCORDING TO THE RADIOLOGICAL FINDINGS, THE CONTRAST MEDIUM THAT WAS INTRODUCED NEAR THE POSITION WAS POSSIBLY PIERCED AND FLOWED TO THE EPICARDIAL ASPECT. IT WAS DIAGNOSED AS A CARDIAC TAMPONADE BY AN ECHOCARDIOGRAPHIC FINDING AS WELL. DRAINAGE WAS PERFORMED WHILE MEDICATING CATECHOLAMINE TO KEEP THE BLOOD PRESSURE. THEN THE BLOOD PRESSURE RECOVERED. THE PHYSICIAN STATED THAT HE INTERPRETED THE RADIOLOGICAL FINDING MISTAKENLY. HE PUSHED THE CATHETER TO REACH THE TISSUE INSIDE THE CARDIAC CAVITY TOO STRONGLY, BUT ACTUALLY IT WAS OUTSIDE THE CARDIAC CAVITY. THE CARDIAC TAMPONADE WOULD HAVE BEEN CAUSED BY THIS MISTAKE, NOT BY THE CATHETER. NO REPAIR OR TESTING OF THE CARTO 3 SYSTEM WAS NEEDED AS THE ISSUE WAS NOT RELATED TO THE SYSTEM FUNCTIONALITY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: SMART TOUCH BIDIRECTIONAL CATHETER MODEL #: D-1327-01-S, LOT #: 15644666M. THE CATHETER HAS NOT BEEN APPROVED BY US FDA AND IS NOT MARKETED IN THE US. THE DEVICE WILL NOT BE RETURNED TO BIOSENSE WEBSTER FOR ANALYSIS. (B)(4). UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE ON THE EVENT. THERE WERE NO OTHER FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE TAMPONADE. THE USER DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER AND DID NOT NOTICE ANY ABNORMAL SIGNALS. IT WAS UNKNOWN HOW MANY ABLATIONS THE PATIENT RECEIVED BEFORE THE EVENT. THE RF GENERATOR WAS SET TO "POWER-CONTROL" MODE. THE TEMPERATURE CUT-OFF SETTING AND THE FLOW SETTING WERE UNKNOWN. IT WAS UNKNOWN WHICH SHEATH WAS USED AND IF ANY ANTICOAGULATION WAS USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WERE TWO ISSUES. FIRST ISSUE. A FORCE VECTOR OF THE SMART TOUCH BIDIRECTIONAL CATHETER WAS INDICATED IN THE OPPOSITE DIRECTION WHEN THE CATHETER CONTRACTED IN A LATERAL DIRECTION. THE PROCEDURE WAS CARRIED ON WITH THE CATHETER BECAUSE THERE WAS NO PROBLEM EXCEPT THAT ISSUE. THIS ISSUE IS HIGHLY DETECTABLE AND DEEMED NOT REPORTABLE. SECOND ISSUE. THE PHYSICIAN CONFIRMED THE FLUOROSCOPE DURING SEQUENTIAL ABLATION OF THE POSTERIOR WALL OF THE RSPV. THEN IT WAS FOUND THAT THE SMART TOUCH BIDIRECTIONAL CATHETER PROJECTED OUT FROM THE CARDIAC OUTLINE A LITTLE. THE BLOOD PRESSURE REDUCTION WAS ALSO OBSERVED. ACCORDING TO THE RADIOLOGICAL FINDINGS, THE CONTRAST MEDIUM THAT WAS INTRODUCED NEAR THE POSITION WAS POSSIBLY PIERCED AND FLOWED TO THE EPICARDIAL ASPECT. IT WAS DIAGNOSED AS A CARDIAC TAMPONADE BY AN ECHOCARDIOGRAPHIC FINDING AS WELL. DRAINAGE WAS PERFORMED WHILE MEDICATING CATECHOLAMINE TO KEEP THE BLOOD PRESSURE. THEN THE BLOOD PRESSURE RECOVERED. SO THE MINIMUM PROCEDURES (PVI AND CTI ABLATION) WERE CONDUCTED AND THE PROCEDURE WAS CONCLUDED. AFTER THE PROCEDURE, THE PATIENT WAS CARRIED TO THE ICU JUST IN CASE, BUT THE PATIENT'S BLOOD PRESSURE WAS STABLE. THE PHYSICIAN STATED THAT HE INTERPRETED THE RADIOLOGICAL FINDING MISTAKENLY. HE PUSHED THE CATHETER TO REACH THE TISSUE INSIDE THE CARDIAC CAVITY TOO STRONGLY, BUT ACTUALLY IT WAS OUTSIDE THE CARDIAC CAVITY. THE CARDIAC TAMPONADE WOULD HAVE BEEN CAUSED BY THIS MISTAKE, NOT BY THE CATHETER. THE POWER OF ABLATION OF THE POSTERIOR WALL OF RSPV WAS 30W. CONDUCT FORCES VARIED; MAXIMUM WAS 127G. THE AVERAGE AT ONE POINT WAS 97G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64998 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R