THERMOCOOL SMARTTOUCH SF
Report
- Report Number
- 2029046-2025-03344
- Event Type
- Injury
- Date Received
- October 2, 2025
- Report Date
- November 11, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- PMA / PMN Number
- P030031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DURING AN INTERNAL REVIEW ON 17-OCT-2025, NOTED A CORRECTION TO THE 3500A INITIAL AS IN THE B5 EVENT DESCRIPTION INCLUDED, ¿AN 8FRENCH CS WEBSTER CATHETER, SMARTTOUCH SF F CURVE CATHETER, AND PENTARAY CATHETER WERE IN THE HEART THE MOMENT IT WAS DISCOVERED THE PATIENT HAD A PERICARDIAL EFFUSION.¿ HOWEVER, IT SHOULD HAVE STATED, ¿A SOUNDSTAR 8FRENCH, CS WEBSTER CATHETER, SMARTTOUCH SF F CURVE CATHETER, AND PENTARAY CATHETER WERE IN THE HEART THE MOMENT IT WAS DISCOVERED THE PATIENT HAD A PERICARDIAL EFFUSION.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 17-OCT-2025 WHICH CLARIFIED THAT THE SMARTTOUCH SF F CURVE CATHETER REFERS TO THE THMCL SMTCH SF UNID, TC, F. THEREFORE, UPDATED THE FOLLOWING INFORMATION INITIALLY REPORTED UNDER THE 3500A INITIAL REPORT: -D4. CATALOG FROM UNK_SMART TOUCH UNIDIRECTIONAL SF TO D134702. -G4. PMA/ 510(K) FROM P030031/S078 TO P030031. -UPDATING INITIAL STATEMENT INCLUDED UNDER H11. ADDITIONAL MANUFACTURER NARRATIVE WHICH WAS REPORTED AS THE FOLLOWING: ¿D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.¿ THE UPDATED STATEMENT IS THE FOLLOWING: ¿D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.¿ IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED DRAINAGE/PERICARDIOCENTESIS WITH EXTENDED HOSPITALIZATION BECAUSE OF TRANSFER TO SURGERY. INITIALLY, IT WAS REPORTED THAT THERE WAS AN ALERT 105: CATHETER SENSOR ERROR. ALTHOUGH WE COULD SEE THE SIGNALS, WE WERE UNABLE TO VISUALIZE THE MAP ON CARTO. THE PHYSICIAN CONFIRMED THAT THE ABLATION CATHETER WAS IN THE HEART (RIGHT SIDED) USING FLUOROSCOPY. WE THEN REPLACED THE ABLATION CABLE, BUT THE ERROR PERSISTED. AFTER REPLACING THE ABLATION CATHETER WITH A NEW ONE, WE WERE ABLE TO CONTINUE WITH THE PROCEDURE. THEN, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AFTER EXAMINING THE HEART ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TOWARDS THE END OF THE PROCEDURE. THE PHYSICIAN PERFORMED A PERICARDIAL PUNCTURE. THE PATIENT REMAINED STABLE AND CALM THROUGHOUT THE WHOLE PROCEDURE (VITAL SIGNS AND O2 SATURATION WERE NORMAL). THE EFFUSION AND DRAINAGE/PERICARDIOCENTESIS WERE MONITORED VIA ICE FOR A MINIMUM OF ONE HOUR BEFORE THE PATIENT WAS TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT (ICU). ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EFFUSION REMAINS UNKNOWN. THE SURGERY WAS DELAYED FOR 1+ HOUR. ADDITIONAL INFORMATION WAS RECEIVED. AN 8FRENCH CS WEBSTER CATHETER, SMARTTOUCH SF F CURVE CATHETER, AND PENTARAY CATHETER WERE IN THE HEART THE MOMENT IT WAS DISCOVERED THE PATIENT HAD A PERICARDIAL EFFUSION. THE INTERVENTION PROVIDED WAS AF ABLATION AND A PERICARDIAL TAP WAS PERFORMED BY THE PHYSICIAN. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF TRANSFER TO SURGERY. THE PROCEDURAL ACT WAS WITHIN RECOMMENDED VALUE. ONE CATHETER EXCHANGE OCCURRED DURING THE PROCEDURE. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE WITH ABBOTT BRK TRANSSEPTAL NEEDLE. THE NUMBER OF PERFORMED ABLATIONS WERE 88 ABLATIONS WITH RF ENERGY AND INCLUDED THE PULMONARY VEINS (PVIS) AND THE CARINA. PRIOR TO NOTING THE PERICARDIAL EFFUSION (PE) ABLATION WAS PERFORMED. NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED POST ABLATION. THE FLOW SETTING FOR IRRIGATED CATHETER WAS STANDARD FOR SMARTTOUCH SF (STSF). THE PATIENT REQUIRED CARDIAC SURGERY. THE CARTO REPLAYS AVAILABLE BUT NOT THE ERROR REPORTING. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP SWITCHED FROM HIGH TO LOW FLOW DURING ABLATION (AUTOMATIC SETTING). NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR, AND VISITAG. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WERE RESP GATED; TIME 3 SECONDS; STABILITY 3MM; FOT 25%; TAG SIZE 3MM; AND TAG INDEX 400/550. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG. THE COLOR OPTION USED PROSPECTIVELY WAS FTI. NGEN GENERATOR WAS USED FOR THE PROCEDURE. THE CATHETER SENSOR ERROR WAS ASSESSED AS NON MDR REPORTABLE. THE INCIDENCE OF MAGNETIC SENSOR ERROR WAS EASY DETECTABLE BY THE USER. THE CATHETER WAS INOPERABLE SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WOULD HAVE TO REPLACE THE CATHETER. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319065 | THERMOCOOL SMARTTOUCH SF | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R| L | ABBOTT BRK TRANSSEPTAL NEEDLE| BI DIR 7FR DEFL CS CATH, NON-| NGEN PUMP, US CONFIGURATION| NGEN RF GENERATOR| PENTARAY NAV ECO 7FR, D, 2-6-2| SOUNDSTAR ECO SMS 8F CATHETER| THMCL SMTCH SF UNID, TC, F| UNK ABLATION CABLE| UNK_CARTO 3 |