BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10947796 · Received December 4, 2020

    Report

    Report Number
    2029046-2020-01870
    Event Type
    Death
    Date Received
    December 4, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 6, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/14/2020. THE GENERATOR SETTINGS WERE POWER CONTROL MODE, THRESHOLD TEMPERATURE CUT OFF 40 C°, POWER CUT OFF POWER RAMP, DURATION OFF. TO AVOID ESOPHAGEAL INJURY POSTERIOR WALL ABLATION INDEX MAX 400 / MAX 25 WATT / MAX 60 SEC. ESOPHAGEAL INJURY WAS CONFIRMED BY TRANSESOPHAGEAL ECHO AND AUTOPSY. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. GENERATOR WAS FOUND DEFECTIVE BECAUSE OF ANOTHER ISSUE AND IT WAS SENT TO THE DEVICE MANUFACTURER. ORIGINALLY THE GENERATOR WAS REPORTED AS "UNK_SMARTABLATE GENERATOR". ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE SYSTEM INFORMATION AS "SMARTABLATE GENERATOR KIT-WW". THEREFORE, PROCESSED THE "D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES" SECTION WAS PROCESSED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). (B)(4). THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT ((B)(6) YEAR OLD, (B)(6) KG, ) UNDERWENT CARDIAC ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT THE PATIENT HAD NORMAL PROCEDURE 1 MONTH PRIOR (ON 6TH OF OCTOBER) AND WAS DISCHARGED HOME WITHOUT PROBLEMS. THE PATIENT WAS READMITTED SEVERAL WEEKS LATER WITH SWALLOWING ISSUES AND MALAISE. IN HOSPITAL MEASURED INFECT PARAMETERS WERE HIGH. DUE TO SWALLOWING ISSUES THE PHYSICIAN ORDERED CT SCAN TO EVALUATE FISTULA. IN CT THERE WAS VISIBLE PERICARDIAL EFFUSION AND AIR IN PERICARDIUM. PATIENT WAS IMMEDIATELY TRANSFERRED BY HELICOPTER TO NEAREST CARDIAC SURGERY CENTER (HERZZENTRUM BERNAU) FOR SURGICAL RELIEF OF EFFUSION. IN PERICARDIUM THERE WAS FOUND PUS / MATTER (NO BLOOD) AND PATIENT DEVELOPED SEPSIS. DUE TO UNDERLYING SERIOUS LUNG DISEASE CONGESTIVE OBSTRUCTIVE PULMONARY DISORDER (COPD) AND LUNG EMPHYSEMA THE PATIENT WENT INTO PULMONARY FAILURE AND RECEIVED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. DUE TO BAD CONDITION AND INCREASING INFECT PARAMETERS THE PATIENT DIED (EXACT DATE IS UNKNOWN). ACCORDING TO INFORMATION THAT THE PHYSICIAN SUPPLIED VIA TELEPHONE FROM THE HEAD OF CARDIAC SURGERY IN BERNAU THERE WAS NO ATRIOESOPHAGEAL FISTULA AND NO VISIBLE THERMAL INJURY THAT COULD BE A RESULT OF THE RADIOFREQUENCY ABLATION. THERE WAS A LARGE DEFECT BETWEEN ESOPHAGUS AND LOWER PERICARDIAL SACK THAT LED TO THE PERICARDIAL EFFUSION OF PUS AND AIR. THE PHYSICIAN¿S OPINION IS THAT THE CAUSE OF DEATH WAS ESOPHAGEAL PERFORATION AND PERICARDIAL FISTULA. GRAPH, DASHBOARD, VECTOR AND VISITAG WERE USED FOR FORCE VISUALIZATION DURING PROCEDURE. THE VISITAG STABILITY SETTINGS WERE 2.5 MM/ 3 SEC, TAG INDEX, FORCE OVER TIME 25% OF 3G, RESPIRATORY ADJUSTMENT. ABLATION INDEX WAS USED AS COLOR OPTION. TRANSSEPTAL WAS PERFORMED DURING PROCEDURE AND WAS UNEVENTFUL. THERE WAS NO EVIDENCE OF STEAM POP. STANDARD IRRIGATION SETTINGS WERE USED (ML/MIN LOW FLOW, BIS 30 WATT 8 ML/MIN AB 31 WATT 15ML/MIN HIGH FLOW). AFTER REVIEW, IT WAS DETERMINED THAT THIS IS HIGHLY UNUSUAL AND UNLIKELY. WITH THE EVIDENCE PRESENTED AND THE MANNER IN WHICH THE PATIENT PRESENTED BEING SO CONSISTENT WITH ESOPHAGEAL FISTULA, WE CANNOT SUGGEST AN ALTERNATIVE EXPLANATION. THEREFORE, IT WAS ASSESSED AS AN ESOPHAGEAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413432 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R CARTO 3 SYSTEM| LASSO NAV 2515,22P SPLITHANDLE| SMARTABLATE GENERATOR KIT-WW| UNK_SMARTABLATE GENERATOR| CARTO 3 SYSTEM| LASSO NAV 2515,22P SPLITHANDLE| UNK_SMARTABLATE GENERATOR