THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
Report
- Report Number
- 2029046-2023-01380
- Event Type
- Death
- Date Received
- June 26, 2023
- Date of Event
- May 30, 2023
- Report Date
- August 1, 2023
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835009781
- PMA / PMN Number
- P030031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WAS RECEIVED ON 06-JUL-2023. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THE DATE OF DEATH IS UNKNOWN. HOWEVER, THEY WERE INFORMED THAT THE PATIENT WAS DEAD ON (B)(6) 2023. THE BWI REPRESENTATIVE WAS NOT CERTAIN OF WHAT THE DOCTOR BELIEVES WAS THE CAUSE OF DEATH. THE BWI REPRESENTATIVE PROVIDED THE FOLLOWING DETAILS SURROUNDING THE DEATH EVENT: ON 30-MAY-2023, THE BWI REPRESENTATIVE ENTERED THE LAB, THE DOCTOR WAS MONITORING A POSSIBLE EFFUSION ON INTRACARDIAC ECHO, SOMETHING SHE COULD SEE FROM THE CONTROL ROOM OUTSIDE THE PROCEDURE. SHE DID A QUICK CASE UPDATE WITH HER COLLEAGUE, ANOTHER BWI REPRESENTATIVE, WHO LET HER KNOW THAT THE DOCTOR HAD SEEN A POSSIBLE EFFUSION AFTER FINISHING ABLATION THERAPY, AND HE WAS HOLDING/PULLING CATHETERS UNTIL HE MADE A DECISION ON WHETHER OR NOT TO INTERVENE WITH THE EFFUSION. THE STAFF WAS CONCERNED ABOUT THE BLOOD PRESSURE, AND ANESTHESIA AND THE NURSING STAFF WERE RE-RUNNING BLOOD PRESSURE READINGS, AND DURING THIS TIME, SHE NOTED ON THE RECORDING SYSTEM THAT THE PATIENT EITHER HAD VERY LITTLE OR NO CARDIAC ACTIVITY. THIS WAS POINTED OUT TO THE OTHER BWI REPRESENTATIVE, WHO INFORMED THE PHYSICIAN THE PATIENT HAD LOST HEARTBEAT, AT WHICH POINT A CODE WAS CALLED. ADDITIONAL NURSING STAFF CAME IN FROM OTHER DEPARTMENTS AND DELIVERED CPR FOR A NUMBER OF MINUTES. THE DEPARTMENT MANAGER WAS INFORMED THAT THERE WAS A PERFORATION AND PERICARDIAL EFFUSION. PHYSICIAN THEN USED A PERICARDIOCENTESIS KIT TO TAP THE CHEST, AND WAS ASPIRATING BLOOD FROM THE PERICARDIAL CAVITY AND CIRCULATING IT DIRECTLY INTO THE PATIENT. APPROXIMATELY 300 CC¿S OF BLOOD WAS ASPIRATED DURING THE TIME THAT THE PATIENT WAS IN ROOM. ADDITIONALLY, THE PHYSICIAN ORDERED A XARELTO ANTIDOTE, AS WELL AS ANESTHESIA REVERSING THE HEPARIN, TO HELP THE PATIENT COAGULATE. AFTER A NUMBER OF MINUTES ASPIRATING AND PERFORMING CPR, THE PATIENT REGAINED A HEARTBEAT, AND THE CARDIOTHORACIC SURGEON ON CALL WITH THE PHYSICIAN BELIEVED, AT THE TIME, THE PATIENT COULD BE MEDICALLY MANAGED, AND THE PATIENT WAS CONNECTED TO A DRAINAGE BAG AND WHEELED OUT OF THE OR FOR MEDICAL MANAGEMENT. ON (B)(6) 2023, THE HOSPITAL STAFF INFORMED THE BWI REPRESENTATIVE THAT THE PATIENT ENDED UP NEEDING A REPAIR FROM THE CARDIOTHORACIC SURGEON ON THE EVENING OF (B)(6) 2023 AND WAS STILL ADMITTED IN HOSPITAL. ON (B)(6) 2023, THE PHYSICIAN EXPRESSED CONCERN ABOUT TWO THINGS REGARDING THIS CASE, ONE WAS A STEAM POP THAT HE HAD NOT RELAYED TO THE BWI REPRESENTATIVES ON THE DAY OF THE PROCEDURE, AND CONCERN ABOUT THE CURRENT LEAKAGE WARNING, WHICH HE THOUGHT COULD CAUSE A ¿SURGE¿ THROUGH THE ABLATION AND BURN THROUGH THE ATRIUM, CAUSING A PERFORATION. HE ECHOED THIS CONCERNS AGAIN ON JUNE 6TH. PER THE ADDITIONAL INFORMATION RECEIVED, THE H 6. HEALTH EFFECT - CLINICAL CODE WAS UPDATED AND CARDIAC ARREST (E0602) WAS ADDED. THE H 6. MEDICAL DEVICE PROBLEM CODE WAS UPDATED AS WELL, AND THE CODE OF PATIENT DEVICE INTERACTION PROBLEM (A01) WAS ADDED TO REPRESENT THE STEAM POP REPORTED ON (B)(6) . STEAM POP IS NOT CONSIDERED TO BE A DEVICE MALFUNCTION. STEAM POP IS AN EXPECTED PHYSIOLOGICAL PHENOMENON. THEREFORE, STEAM POP IS NOT MDR REPORTABLE. THE CURRENT LEAKAGE ISSUE IS NOT MDR REPORTABLE. THIS ISSUE IS HIGHLY DETECTABLE AND REQUIRES ADJUSTING SYSTEM COMPONENTS TO CONTINUE WITH THE PROCEDURE. PATIENT SAFETY IS UNAFFECTED BY THIS ISSUE. DEVICE EVALUATION DETAILS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN AFIB - PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE (CT) REQUIRING A PERICARDIOCENTESIS AND ULTIMATELY PASSED AWAY. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION ON 03-JUL-2023. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 30960902L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE PHYSICIAN BELIEVES THAT THE ISSUE COULD HAVE BEEN PROCEDURE RELATED OR PRODUCT RELATED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. PRODUCT COMPLAINT # (B)(4).
B2. DATE OF DEATH: THE EXACT DATE OF DEATH IS UNKNOWN AT THIS TIME AND SO THIS FIELD WAS POPULATED WITH THE AWARENESS DATE OF WHEN THE DEATH WAS REPORTED WHICH WAS ON (B)(6)2023. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN AFIB - PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE (CT) REQUIRING A PERICARDIOCENTESIS AND ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT A CURRENT LEAK ERROR 7 WAS DISPLAYED ON THE CARTO 3 SYSTEM MID-WAY THROUGH THE PROCEDURE. THE ABLATION CATHETER CABLE WAS DISCONNECTED AND RECONNECTED AND THE ERROR WAS RESOLVED. THE PROCEDURE CONTINUED. IT WAS ALSO REPORTED THAT WHILE BURNING POSTERIOR UNDERNEATH THE LEFT INFERIOR VEIN, THE PHYSICIAN MOVED THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND NOTED A GROWING PERICARDIAL EFFUSION (PE). THE PATIENT THEN WENT INTO ASYSTOLE, AND A "ROUND OF COMPRESSIONS" WAS PERFORMED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. THERE WERE NO SPIKES IN THE IMPEDANCE READINGS DURING ABLATION. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE STATED THAT 45W WAS USED, 40W POSTERIOR. THE BWI REP ALSO REPORTED THAT THE BACK PATCH CABLES WERE CUT DURING THE RUSH TO STABILIZE THE PATIENT. THEY REQUESTED A REPLACEMENT GREEN PATCH SENSOR CABLE, PN: KT0001420. UNKNOWN SERIAL NUMBER. (UNCONFIRMED V7 SOFTWARE, 7.5.1.327). THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BWI PRODUCTS. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS 71CM C1. PRIOR TO NOTING THE PE OR CT, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING WAS 8/15 PER INSTRUCTIONS FOR USE (IFU). ERROR MESSAGES OBSERVED WAS CURRENT LEAK EARLIER IN THE CASE. PATIENT WAS HEMODYNAMICALLY STABLE AT THIS TIME. THE EFFUSION WAS DISCOVERED/NOTICED VIA ICE IMAGING. EFFUSION WAS CONFIRMED WITH A SOUNDSTAR. PERICARDIOCENTESIS WAS PERFORMED. FLUID REMOVED WAS 100ML. THE TUBE WAS LEFT IN PLACE. THE PROCEDURE WAS ABANDONED. EVIDENCE OF ANY EFFUSION PRESENT BEFORE THE PROCEDURE WAS TRACE. OTHER BWI PRODUCTS: SOUNDSTAR, OCTARAY, DECANAV, VIZIGO THE ABLATION CATHETER WILL BE RETURNED FOR ANALYSIS. NO REPLACEMENT REQUESTED. THE PHYSICIAN BELIEVED THAT THE ISSUE COULD HAVE BEEN PROCEDURE RELATED OR PRODUCT RELATED. CAUSE IS STILL UNKNOWN. SURGICAL INTERVENTION WAS PERFORMED WITH A CARDIOTHORACIC SURGEON. A LEFT ATRIAL REPAIR WAS PERFORMED ANTERIOR TO THE LEFT INFERIOR PULMONARY VEIN. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AS THE PATIENT WAS SENT TO THE ICU POST PERICARDIAL EFFUSION. THE PATIENT ULTIMATELY PASSED AWAY. THE GENERATOR USED WAS SMARTABLATE GENERATOR STOCKERT GMBH, REF: M490002, S/N: (B)(6). THE CORRECT CATHETER SETTINGS SELECTED ON THE GENERATOR WERE CUSTOM SETTINGS PER PHYSICIAN PREFERENCE: PRE-RF FLUID TIME: 0 SECONDS; POST-RF FLUID TIME: 0 SECONDS; HIGH FLOW: 8.15 ML; LOW FLOW: 2 ML; 45 WATTS. THE PUMP SWITCHING WAS FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. ALL FORCE VISUALIZATION FEATURES WERE USED. FORCE VISUALIZATION FEATURES WERE GRAPH, DASHBOARD, VECTOR, AND VISITAG. THE VISITAG MODULE WAS USED, PARAMETERS FOR STABILITY USED WAS -3 ¿ 3 ¿25 ¿ 3 STANDARD SETTINGS FOR PARAMETERS AND TAG SIZE 3MM. ADDITIONAL FILTER USED WITH THE VISITAG WAS RESPIRATION GATED. FTI WAS USED. THE "CURRENT LEAKAGE ERROR" WAS DISPLAYED DUE TO A SIGNAL NOISE/LOSS ISSUE. TOWARDS THE END OF THE CASE ¿ NO ISSUES THROUGHOUT THE CASE THEN PHYSICIAN STEPPED ON PEDAL LEAKAGE ERROR WARNING APPEARED. THEY CHANGED CABLE AND ISSUE WAS RESOLVED. THERE WAS NO SIGNAL LOSS ON BS AND NO SIGNAL LOSS ON IC. NO SIGNAL LOSS ON CARTO® AND RECORDING SYSTEM. THERE WAS ECG/EKG SIGNAL AVAILABLE FOR THE PHYSICIAN TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CURRENT LEAKAGE IS NOT MDR REPORTABLE. THIS ISSUE IS HIGHLY DETECTABLE AND REQUIRES ADJUSTING SYSTEM COMPONENTS TO CONTINUE WITH THE PROCEDURE. DEVICES MAY REQUIRE RESET OR REPLACING BUT CANNOT BE USED ON THE PATIENT. PATIENT SAFETY IS UNAFFECTED BY THIS ISSUE. THE C-3 LOCATION PATCH ISSUE IS NOT MDR REPORTABLE. THIS IS HIGHLY DETECTABLE. MOST LIKELY HARM IS PROCEDURE DELAY OR CANCELLATION. ALL DEATHS WERE A BWI, FDA APPROVED ¿ CE MARK DEVICES ARE INVOLVED ARE MDR REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 931428 | THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | D134702 | 30960902L | 10846835009781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Death| L| H| R | CARTO 3 SYSTEM| GREEN PATCH SENSOR CABLE KIT| GREEN PATCH SENSOR CABLE KIT| SMARTABLATE GENERATOR SPARE-US| UNK BAYLIS 71CM C1| UNK DECANAV| UNK_CARTO VIZIGO SHEATH| UNK_OCTARAY NAV| UNK_SOUNDSTAR |