THERMOCOOL SMARTTOUCH SF
Report
- Report Number
- 2029046-2026-00612
- Event Type
- Injury
- Date Received
- February 23, 2026
- Date of Event
- January 20, 2026
- Report Date
- May 13, 2026
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835010183
- PMA / PMN Number
- P030031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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).
ON 9-MAR-2026, BWI RECEIVED ADDITIONAL INFORMATION INDICATING THAT LESS FLUID WAS GIVEN THAN EXPECTED. AND THAT THE ISSUE WAS INDEED IDENTIFIED BY AN AUDIBLE ALARM ALONG WITH VISUALLY CONFIRMING A CLOT IN THE CARDIAC CAVITY. THERE WERE MULTIPLE CORRECTIONS IDENTIFIED PER INTERNAL REVIEW: B6 TESTS/LAB DATA INCLUDING DATES MISTAKENLY CONTAINED THE MEDICAL HISTORY, SO THAT INFORMATION HAS BEEN MOVED TO SECTION B7 OF THIS REPORT. FURTHERMORE, INTERNAL REVIEW HAS DETERMINED THAT THE H6 HEALTH EFFECT - CLINICAL CODE OF "THROMBOSIS/THROMBUS" (E0514) APPLIES TO THIS EVENT. THE B5 EVENT DESCRIPTION FROM THE INITIAL REPORT HAS BEEN REWRITTEN/REORGANIZED FOR CLARITY. HERE IS THE UPDATED VERSION: IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL SMARTTOUCH CATHETER AND THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT THAT REQUIRED ICU (INTENSIVE CARE UNIT) ADMISSION. AT A CERTAIN POINT DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, THE IRRIGATION PUMP FAILED TO DELIVER THE APPROPRIATE VOLUME REQUIRED FOR IRRIGATION AND COOLING OF THE STSF CATHETER TIP. THE EQUIPMENT DID NOT PRESENT ANY ALERT IN THE SYSTEM, AND THE IDENTIFICATION OF THE INTERCURRENCE PERFORMED BY VISUAL OBSERVATION OF THE JOHNSON TECHNICIAN. ELEVATED TEMPERATURE AT THE TIP WAS OBSERVED. UPON IDENTIFICATION OF THE INTERCURRENCE, THE RESPONSIBLE PHYSICIAN INTERRUPTED THE PROCEDURE AND PERFORMED THE CATHETER REMOVAL, AND THE PRESENCE OF A CLOT WAS OBSERVED IN ITS DISTAL EXTREMITY. IT WAS REPORTED THAT THE ISSUE WAS OBSERVED THROUGH AN AUDIBLE ALARM AND CLOT IN THE CARDIAC CAVITY. THE CLOT WAS OBSERVED AFTER THE ALARM. THERE WERE NO ERRORS DISPLAYED ON THE SCREEN. AS A RESULT OF THE EVENT, THE PROCEDURE WAS CLOSED AFTER THE PATIENT PRESENTED CEREBRAL VASCULAR ACCIDENT (STROKE). PATIENT HAD SYMPTOM OF RIGHT HAND NUMBNESS. THE PATIENT WAS REFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE HE REMAINED FOR THREE DAYS FOR CLINICAL OBSERVATION AND FOLLOW-UP BY A MULTIDISCIPLINARY TEAM. PATIENT WAS HOSPITALIZED ON (B)(6) (DATE OF THE EXAM), (B)(6), AND DISCHARGED ON (B)(6). HOSPITALIZATION WAS ONLY FOR MONITORING OF ANY POSSIBLE EVOLUTION OF SEQUELAE. IT'S WORTH NOTING THAT THE PATIENT LEFT THE HOSPITAL WALKING AND TALKING, ONLY EXPERIENCING NUMBNESS IN HIS RIGHT HAND. IT WAS REPORTED LATER THAT THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK NOT A STROKE, HOWEVER THE PHYSICIAN CONFIRMED IT WAS A CVA (CEREBROVASCULAR ACCIDENT). A CT (COMPUTED TOMOGRAPHY) WAS DONE. PATIENT'S SYMPTOMS RESOLVED 70% PATIENT HAS A HISTORY OF STROKE IN 2025. PATIENT ALSO WAS REPORTED TO BE AN ELDERLY MALE (75 YEARS OLD) WITH HEART DISEASE. THERE WAS RF (RADIOFREQUENCY) ABLATION, ISOLATION OF THE FOUR PULMONARY VEINS WERE PERFORMED. AN "ICT" (INTERATRIAL CONDUCTION TIME) BLOCK WAS PERFORMED OUTSIDE OF THE PULMONARY VEINS. PATIENT WAS IN SINUS RHYTHM DURING ABLATION. IT WAS BELIEVED THERE WAS A PRE-ABLATION THROMBUS CHECK. THE PATIENT HAD NO ANATOMICAL ABNORMALITIES. NO STACKING OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED CEREBRAL VASCULAR ACCIDENT (STROKE). THE PATIENT WAS REFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE HE REMAINED FOR THREE DAYS FOR CLINICAL OBSERVATION AND FOLLOW-UP BY A MULTIDISCIPLINARY TEAM. THE REPORT INDICATED THAT DURING AFIB ABLATION PROCEDURE OF ATRIAL FIBRILLATION ABLATION WITH SMARTABLATE PUMP AND SMART TOUCH BIDIRECTIONAL CATHETER, IDENTIFIED THAT, AT ONE POINT IN THE PROCEDURE, THE IRRIGATION PUMP NO LONGER PROVIDES THE APPROPRIATE VOLUME FOR IRRIGATION AND COOLING OF THE TIP OF THE STSF CATHETER. IT WAS REPORTED THAT THE EQUIPMENT DID NOT PRESENT ANY ALERT IN THE SYSTEM, AND THE IDENTIFICATION OF THE INTERCURRENT PERFORMED BY VISUAL OBSERVATION OF THE JOHNSON & JOHNSON TECHNICIAN. UPON IDENTIFICATION OF THE INTERCURRENCE, THE RESPONSIBLE PHYSICIAN INTERRUPTED THE PROCEDURE AND PERFORMED THE CATHETER REMOVAL, AND THE PRESENCE OF A CLOT WAS OBSERVED IN ITS DISTAL EXTREMITY. AS A RESULT OF THE EVENT, THE PROCEDURE WAS CLOSED AFTER THE PATIENT PRESENTED CEREBRAL VASCULAR ACCIDENT (STROKE). THE PATIENT WAS REFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE HE REMAINED FOR THREE DAYS FOR CLINICAL OBSERVATION AND FOLLOW-UP BY A MULTIDISCIPLINARY TEAM. AT THE SAME TIME, A CALL WAS INITIATED TO RESEARCH AND TECHNICAL ANALYSIS OF THE EQUIPMENT INVOLVED, ACCORDING TO THE APPLICABLE INTERNAL PROTOCOLS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE PUMP STOPPED IRRIGATING THE CATHETER. NO INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS SUSPENDED WHEN THE CLOT WAS IDENTIFIED AT THE CATHETER TIP. THE KIND OF NEUROLOGICAL IMPAIRMENT WAS TRANSIENT ISCHEMIC ATTACK (TIA) CONFIRMED WITH COMPUTED TOMOGRAPHY (CT SCAN) WITH NEUROLOGICAL ISSUE OF NUMBNESS IN THE RIGHT HAND. THE PATIENT¿S SYMPTOMS UP TO THE DAY OF DISCHARGE HAD RESOLVED 70%. THE OUTCOME OF THE ADVERSE WAS THAT THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND DISCHARGED ON THE THIRD DAY. THE HOSPITALIZATION WAS ONLY FOR MONITORING OF ANY POSSIBLE EVOLUTION OF SEQUELAE. THE PATIENT LEFT THE HOSPITAL WALKING AND TALKING, AND ONLY EXPERIENCING NUMBNESS IN HIS RIGHT HAND. RELEVANT TESTS/LABORATORY DATA WAS CASE OF STROKE IN 2025. OTHER RELEVANT HISTORY/PREEXISTING CONDITION WERE COMORBIDITIES OF PREVIOUS STROKE, ELDERLY, AND HEART DISEASE. THE CATHETERS AND SHEATHS WERE NOT CHANGED AT ANY TIME DURING THE PROCEDURE. ONE TRANSSEPTAL PUNCTURE WAS PERFORMED DURING THE PROCEDURE. RF (RADIOFREQUENCY) ABLATION ENERGY WAS DELIVERED FOR ISOLATION OF THE FOUR PULMONARY VEINS. INTERATRIAL CONDUCTION TIME BLOCK (ICT) WAS CONDUCTED OUTSIDE THE PULMONARY VEINS. THERE WERE EVIDENCE CHAR AND THROMBUS/CLOT DURING THE PROCEDURE. THE PATIENT HAD A PREVIOUS HISTORY OF STROKE. THE CORRECT CATHETER SETTING WAS SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. NO OTHER OBSERVATIONS SUCH AS INTRACARDIAC EXCESSIVE MICROBUBBLES OBSERVED VIA ULTRASOUND, BUT ONLY ELEVATED TEMPERATURE AT THE TIP, WHEN THE PROBLEM WAS OBSERVED. THE PATIENT¿S RHYTHM DURING ABLATION WAS SINUS. THE TYPE OF ELECTROPHYSIOLOGY PROCEDURE PERFORMED WAS NEW PAF (PAROXYSMAL ATRIAL FIBRILLATION). IT IS BELIEVED THAT PRE-ABLATION THROMBUS CHECK WAS PERFORMED. THE PATIENT DID NOT HAVE ANY ANATOMICAL ABNORMALITIES. NO STACKING OCCURRED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 544913 | THERMOCOOL SMARTTOUCH SF | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | 31678515L | 10846835010183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention| L| H | CARTO 3 SYSTEM.| SMARTABLATE PUMP KIT-WW. |