THERMOCOOL SMARTTOUCH SF
Report
- Report Number
- 2029046-2025-02149
- Event Type
- Injury
- Date Received
- July 1, 2025
- Date of Event
- June 9, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835010183
- PMA / PMN Number
- P030031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON 25-JUN-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A VARIPULSE¿ CATHETER AND A THERMOCOOL SMARTTOUCH® SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. TOWARDS THE END OF THE CASE, AFTER ABLATION WAS ALREADY COMPLETED WITH BOTH THE VARIPULSE¿ CATHETER AND THERMOCOOL SMARTTOUCH® SF CATHETER, A DROP ON BLOOD PRESSURE WAS DISCOVERED AND THE CARDIAC TAMPONADE WAS CONFIRMED BY ECHO; THE DOCTOR USED ULTRASOUND PROBE TO LOCATE THE PERICARDIAL EFFUSION. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS MOVED TO CRITICAL CARE UNIT (CCU) OVERNIGHT FOR RECOVERY. PATIENT WAS STABLE THE NEXT DAY. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J 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. DURING PRODUCT ANALYSIS, THE DEVICE LOT NUMBER WAS VERIFIED AS 31568914L. AS SUCH, FIELDS D4. LOT, D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED APPROPRIATELY. ADDITIONALLY, THE FULL UDI HAS NOW BEEN PROVIDED UNDER FIELD D4. PRIMARY UDI NUMBER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS, OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNING AND PRECAUTIONS: WHEN USING THE CATHETER WITH CONVENTIONAL SYSTEMS (USING FLUOROSCOPY TO DETERMINE CATHETER TIP LOCATION), OR WITH THE CARTO¿ 3 SYSTEM, CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED. THE FIRMNESS OF THE BRAIDED TIP DICTATES THAT CARE MUST BE TAKEN TO PREVENT PERFORATION OF THE HEART. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A VARIPULSE¿ CATHETER AND A THERMOCOOL SMARTTOUCH® SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. TOWARDS THE END OF THE CASE, AFTER ABLATION WAS ALREADY COMPLETED WITH BOTH THE VARIPULSE¿ CATHETER AND THERMOCOOL SMARTTOUCH® SF CATHETER, A DROP ON BLOOD PRESSURE WAS DISCOVERED AND THE CARDIAC TAMPONADE WAS CONFIRMED BY ECHO; THE DOCTOR USED ULTRASOUND PROBE TO LOCATE THE PERICARDIAL EFFUSION. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS MOVED TO CRITICAL CARE UNIT (CCU) OVERNIGHT FOR RECOVERY. PATIENT WAS STABLE THE NEXT DAY. THE PHYSICIAN SAID IT COULD HAD BEEN ANY OF THREE AREAS WHERE HE ABLATED: CORONARY SINUS WITH RADIOFREQUENCY (RF), SEPTAL WALL OF RIGHT ATRIUM (RA) WITH RF, OR SUPERIOR VENA CAVA (SVC) WITH RF AND PULSED FIELD ABLATION (PFA). ACTIVATED CLOTTING TIME (ACT) WAS 345. NO TRANSSEPTAL PUNCTURE WAS DONE, EVERYTHING WAS DONE INSIDE THE RA. SEDATION USED WAS WHAT THEY CALL "DEEP SEDATION", PATIENT DID NOT HAVE GENERAL ANESTHESIA, PATIENT WAS NOT INTUBATED DURING PROCEDURE. THEY USED REGULAR FLOW RATE SETTINGS FOR THE THERMOCOOL SMARTTOUCH® SF CATHETER AND 30ML FOR IRRIGATION WITH VARIPULSE CATHETER DURING ABLATION. ALL FORCE VISUALIZATION FEATURES WERE USED WITH THE THERMOCOOL SMARTTOUCH® SF CATHETER. THEY USED IMPEDANCE RANGE 0-10 OHMS TO COLOR THE VISITAGS. THE PARAMETERS FOR THE VISITAGS WERE 3S,3MM,25% AND 3G. NO ERRORS WERE OBSERVED DURING APPLICATION OF ENERGY (RF OR PF).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1130545 | THERMOCOOL SMARTTOUCH SF | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | 31568914L | 10846835010183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| L| R | 8.5 FR VARIPULSE CATHETER| CARTO 3| DECANAV CATHETER| NGEN RF GENERATOR| TRUPULSE GENERATOR| ULTRASOUND PROBE| UNK_CARTO VIZIGO SHEATH| WEBSTER QUADRAPOLAR CATHETER |