THERMOCOOL SMARTTOUCH SF
Report
- Report Number
- 2029046-2026-00289
- Event Type
- Death
- Date Received
- January 22, 2026
- Date of Event
- December 29, 2025
- Report Date
- January 22, 2026
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835010183
- PMA / PMN Number
- P030031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE HAD BEEN DISCARDED. 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. 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).
AFTER THE ACCESSORY PATHWAY ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION CORRECTED BY THE PHYSICIAN. HOWEVER, THE PATIENT PASSED AWAY LATER DURING THE NIGHT. THE REPORT INDICATED THAT THE PATIENT HAD A PERICARDIAC EFFUSION ROUGHLY AFTER 90 MINUTES AFTER THE PROCEDURE. THE PERICARDIAL EFFUSION WAS CORRECTED BY THE PHYSICIAN. HOWEVER, THE PATIENT PASSED AWAY LATER DURING THE NIGHT ON (B)(6) 2025. THERE WERE NO ISSUES DURING THE ACTUAL PROCEDURE IN REGARD TO THE PATIENT INTERFACE UNIT (PIU) OR THE SMARTABLATE SYSTEM. A BWI REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. THE CATHETERS USED DURING THE PROCEDURE WERE SMARTTOUCH SF CATHETER, OCTARAY 252 SF CATHETER, AND WEBSTER CS (CORONARY SINUS) CATHETER. THE CATHETERS WERE DISCARDED. IN PHYSICIAN¿S OPINION, THE CAUSE OF DEATH WAS UNKNOWN. THE PHYSICIAN COMMENTED AT THE TIME THAT THEY THOUGHT THE BLEED WAS LIKELY VENOUS AS THE VOLUME REMOVED WAS 1.5 L, SO IF IT HAD BEEN ARTERIAL, IT WOULD HAVE BEEN QUICK. THE DOCTOR NOTED THAT WHEN GOING TO SEE THE PATIENT, 60-90 MINUTES FOLLOWING THE PROCEDURE, THE PATIENT SEEMED ILL. THE MEDICAL TEAM PERFORMED A TRANSTHORACIC ECHO, AND THERE WAS AN EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. 1.5 L WERE DRAINED. THE PATIENT THEN PASSED AWAY LATER OVERNIGHT. THE FORCE SENSING ABLATION CATHETER USED WAS STSF. THE DASHBOARD AND VECTOR WERE ON SCREEN VISIBLE TO THE MEDIC WHILST USING THE ABLATION CATHETER. VISITAG MODULES WERE NOT USED AS THE PATIENT HAD SHIFTED MULTIPLE TIMES. MANUAL ABLATION TAGS WERE BEING USED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN ABBOTT BRK, 71 CM. NO EVIDENCE OF STEAM POP. THE FLOW SETTING WAS STSF. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211403 | THERMOCOOL SMARTTOUCH SF | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | 10846835010183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| R | ABBOTT BRK, 71 CM| CARTO 3 SYSTEM| SMARTABLATE GENERATOR| SMARTABLATE PUMP |