BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11942832 · Received June 4, 2021

    Report

    Report Number
    2029046-2021-00868
    Event Type
    Death
    Date Received
    June 4, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 18-JUN-2021, BIOSENSE WEBSTER INC. RECEIVED INFORMATION INDICATING THERE WAS NO EVIDENCE OF STEAM POP, AND NO ERROR MESSAGE WAS REPORTED. THERE WAS NO PRODUCT MALFUNCTION OBSERVED WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. FOR THE CONCOMITANT SOUNDSTAR CATHETER, WHEN THE 1ST SOUNDSTAR CATHETER WAS INSERTED IN RIGHT ATRIUM AND CONNECTED TO ULTRASOUND EQUIPMENT, THE CATHETER WAS NOT RECOGNIZED BY ULTRASOUND EQUIPMENT AND THE ULTRASOUND IMAGES WERE NOT DISPLAYED. THEN THE 1ST SOUNDSTAR CATHETER WAS EXCHANGED TO 2ND SOUNDSTAR CATHETER, AND THE PROCEDURE WAS CONTINUED WITH 2ND CATHETER. WHEN THE CARTO3 DATA FROM THE PROCEDURE WAS REVIEWED, THE PHYSICIAN SAID THAT IT WAS STATED THAT THE CARDIAC PERFORATION WAS UNLIKELY TO BE ATTRIBUTABLE TO ABLATION BASED ON THE CONTACT FORCE AND IMPEDANCE CHANGE, AND THE DIRECT CAUSE OF PERFORATION WAS UNKNOWN. THE PHYSICIAN ALSO SAID THAT THE ABLATION WITH AN INCREASE IN IMPEDANCE PROBABLY SHOWS THE HEART HAD ALREADY PERFORATED AND JUST IMPEDANCE INCREASED SINCE THE CATHETER RETURNING INTO THE HEART. ON 28-JUN-2021, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE PHYSICIAN'S OPINION ON WHAT THE CAUSE OF DEATH WAS, ¿ALTHOUGH THE CAUSE OF DEATH WAS NOT CLEARLY IDENTIFIED, THE PATIENT DIED ON THE DAY AFTER THE THORACOTOMY SURGERY FOR CARDIAC TAMPONADE, SUGGESTING THAT THE HEMORRHAGE DUE TO CARDIAC PERFORATION LED TO DEATH.¿ CATHETER ABLATION WAS PERFORMED USING BWI PRODUCT FOR THE TREATMENT OF ARRHYTHMIA. WHEN ABLATION AROUND THE LEFT VENTRICULAR POSTERIOR PAPILLARY MUSCLE WAS CONDUCTED FOR SEVERAL TIMES, DECREASED BLOOD PRESSURE WAS CONFIRMED, AND PERICARDIAL EFFUSION WAS CONFIRMED BY ULTRASONOGRAPHY. CARDIAC TAMPONADE WAS CONFIRMED, PERICARDIAL DRAINAGE WAS PERFORMED, BUT BLEEDING DID NOT STOP, AND THE PATIENT PROCEEDED TO THORACOTOMY. DURING THE OPERATION, PERFORATION OF ABOUT 3 CM WAS CONFIRMED IN THE LEFT VENTRICLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, THORACOTOMY AND DEATH. AFTER ABLATION OF THE LEFT VENTRICULAR PAPILLARY MUSCLE SEVERAL TIMES, THE PATIENT¿S BLOOD PRESSURE DECREASED AND PERICARDIAL EFFUSION WAS OBSERVED BY ECHOCARDIOGRAPHY. ABLATION WAS 30 TO 40 SECONDS AT 40 W, AND THE CONTACT FORCE WAS ABOUT 3 ~ 20 G (DURING CHECKED). THERE WAS ABLATION WHERE AN INCREASE IN IMPEDANCE WAS OBSERVED, FOLLOWED BY LEARN NEW. AFTER A WHILE, DECREASED BLOOD PRESSURE OCCURRED. AFTER CARDIAC TAMPONADE OCCURRED, DRAINAGE WAS PERFORMED, BUT BLOOD DID NOT STOP, AND THORACOTOMY WAS PERFORMED. DAYS LATER IT WAS REPORTED THE PATIENT HAD DIED IN THE HOSPITAL. DEVICE INVESTIGATION DETAILS: SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(6) NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(6). MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, THORACOTOMY AND DEATH. AFTER ABLATION OF THE LEFT VENTRICULAR PAPILLARY MUSCLE SEVERAL TIMES, THE PATIENT¿S BLOOD PRESSURE DECREASED AND PERICARDIAL EFFUSION WAS OBSERVED BY ECHOCARDIOGRAPHY. ABLATION WAS 30 TO 40 SECONDS AT 40 W, AND THE CONTACT FORCE WAS ABOUT 3 ~ 20 G (DURING CHECKED). THERE WAS ABLATION WHERE AN INCREASE IN IMPEDANCE WAS OBSERVED, FOLLOWED BY LEARN NEW. AFTER A WHILE, DECREASED BLOOD PRESSURE OCCURRED. AFTER CARDIAC TAMPONADE OCCURRED, DRAINAGE WAS PERFORMED, BUT BLOOD DID NOT STOP, AND THORACOTOMY WAS PERFORMED. DAYS LATER IT WAS REPORTED THE PATIENT HAD DIED IN THE HOSPITAL. THE PHYSICIAN COMMENTED THAT THE LEFT VENTRICULAR POSTERIOR PAPILLARY MUSCLE WAS ABLATED AT 40 W FOR 30 TO 40 SECONDS, BUT THE CONTACT WAS NOT STRONG, SO CARDIAC TAMPONADE WAS SUSPECTED AT THE TIME OF SEPTAL PUNCTURE. (LOW BLOOD PRESSURE DURING THE PROCEDURE). THE PATIENT HAD A PERFORATION OF 3 CM IN THE LEFT VENTRICLE AND UNDERWENT THORACOTOMY ON THE 10TH, BUT DIED ON THE 11TH. ADDITIONAL INFORMATION RECEIVED INDICATES THE ADVERSE EVENT WAS DISCOVERED DURING USE BIOSENSE WEBSTER PRODUCTS. CARDIAC DRAINAGE WAS CONDUCTED BUT THE BLEEDING WAS NOT STOPPED AND OPEN SURGERY WAS CONDUCTED. TRANSSEPTAL PUNCTURE WAS PERFORMED, BUT PRODUCT INFORMATION FOR THE NEEDLE WAS UNKNOWN. THERE WAS NO EVIDENCE OF A STEAM POP. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. THE PHYSICIAN RECONFIRMED THE INFORMATION AT THE TIME OF ABLATION, BUT THE CONTACT FORCE AND IMPEDANCE CHANGE MADE IT DIFFICULT TO THINK THAT THE PERFORATION WAS CAUSED BY ABLATION, AND THE DIRECT CAUSE OF THE PERFORATION WAS JUDGED TO BE UNKNOWN. ABLATION WITH INCREASED IMPEDANCE WAS PROBABLY DUE TO PERFORATION ALREADY OCCURRING AND THE RETURN OF THE CATHETER INTO THE HEART. THE REPORTED ISSUE OF HIGH IMPEDANCE IS NOT MDR REPORTABLE SINCE THE USER-DEFINED CUT-OFF WAS NOT EXCEEDED, THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. IT WAS ALSO REPORTED THAT A SOUNDSTAR ECO CATHETER WAS NOT RECOGNIZED ON THE S70 GENERATOR UPON CONNECTING IT. THIS RECOGNITION WAS RESOLVED BY CHANGING THE SOUNDSTAR ECO CATHETER TO ANOTHER ONE. THIS ISSUE WITH THE SOUNDSTAR ECO CATHETER IS NOT CONSIDERED TO BE AN MDR REPORTABLE EVENT SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839924 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30448188M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R S70 GENERATOR| SOUNDSTAR ECO GE 8F CATHETER| UNKNOWN TRANSSEPTAL NEEDLE