THERMOCOOL SMARTTOUCH SF
Report
- Report Number
- 2029046-2025-02911
- Event Type
- Death
- Date Received
- August 28, 2025
- Date of Event
- April 24, 2025
- Report Date
- October 15, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- PMA / PMN Number
- P030031/S078
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED TO UPDATE THE EXTERNAL REFERENCE TO PMID: 40698295 / BW202519127, AS THE SECOND EXTERNAL REFERENCE NUMBER IS USED LOCALLY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
B2. DATE OF DEATH - THE EXACT DATE OF DEATH WAS NOT SPECIFIED. HOWEVER, SINCE IT WAS STATED THAT THE PATIENT DIED WITHIN 2 HOURS POST-PROCEDURE, THE DATE OF DEATH WAS POPULATED WITH THE EVENT DATE. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KASAI Y, KITAI T, MORITA J, HORITA R, KASAI J, FUJITA T. DELAYED LEFT VENTRICULAR RUPTURE AFTER RADIOFREQUENCY CATHETER ABLATION OF PREMATURE VENTRICULAR CONTRACTIONS TRIGGERING VENTRICULAR FIBRILLATION. CJC OPEN. 2025 APR 24;7(7):952-954. DOI: 10.1016/J.CJCO.2025.04.013. PMID: 40698295; PMCID: PMC12277838. 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. 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).
THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KASAI Y, KITAI T, MORITA J, HORITA R, KASAI J, FUJITA T. DELAYED LEFT VENTRICULAR RUPTURE AFTER RADIOFREQUENCY CATHETER ABLATION OF PREMATURE VENTRICULAR CONTRACTIONS TRIGGERING VENTRICULAR FIBRILLATION. CJC OPEN. 2025 APR 24;7(7):952-954. DOI: 10.1016/J.CJCO.2025.04.013. PMID: 40698295; PMCID: PMC12277838. BACKGROUND: DELAYED LEFT VENTRICULAR RUPTURE CAN OCCUR AFTER RADIOFREQUENCY CATHETER ABLATION OF PREMATURE VENTRICULAR CONTRACTIONS TRIGGERING VENTRICULAR FIBRILLATION, EVEN IN THE ABSENCE OF PROCEDURAL COMPLICATIONS SUCH AS STEAM POPS, HIGHLIGHTING A RARE BUT LIFE-THREATENING LATE COMPLICATION. OBJECTIVE: THIS CASE HIGHLIGHTS A RARE BUT CATASTROPHIC COMPLICATION OF RFCA, EMPHASIZING THE NEED FOR VIGILANT POSTPROCEDURAL MONITORING TO DETECT DELAYED STRUCTURAL DAMAGE. METHODS: AN 84-YEAR-OLD MAN WITHOUT ORGANIC HEART DISEASE (MAGNETIC RESONANCE IMAGING WAS NOT PERFORMED BECAUSE OF CLAUSTROPHOBIA EXPERIENCED FREQUENT EPISODES OF VENTRICULAR FIBRILLATION (VF), RESULTING IN AN ELECTRICAL STORM. DESPITE ADMINISTRATION OF ANTIARRHYTHMIC DRUGS, THE VF EPISODES COULD NOT BE CONTROLLED. A SINGLE MORPHOLOGY OF PREMATURE VENTRICULAR CONTRACTIONS WAS CONSISTENTLY IDENTIFIED AS THE TRIGGER FOR VF, AND RADIOFREQUENCY CATHETER ABLATION (RFCA) WAS PERFORMED (FIG. 1, A AND B). DURING THE PROCEDURE, VF REPEATEDLY OCCURRED AGAIN (ELECTRICAL STORM). IMMEDIATE EXTRACORPOREAL MEMBRANE OXYGENATION WAS INITIATED FOR CIRCULATORY SUPPORT. RADIOFREQUENCY ENERGY WAS APPLIED TO THE EARLIEST ACTIVATION SITE OF THE PREMATURE VENTRICULAR CONTRACTIONS, LOCATED AT THE INFERIOR WALL OF THE LEFT VENTRICLE (LV), USING A 3.5-MM OPEN IRRIGATED CATHETER (THERMOCOOL SMARTTOUCH SURROUND FLOW; BIOSENSE WEBSTER, IRVINE, CA). CONCLUSIONS: MOREOVER, IT RAISES CONCERNS ABOUT THE INHERENT VULNERABILITY OF THE INFERIOR LV WALL5 TO RADIOFREQUENCY-INDUCED INJURY AND THE POTENTIAL EXACERBATION OF MYOCARDIAL STRESS DUE TO INCREASED INTRATHORACIC OR INTRACARDIAC PRESSURE DURING THE POSTPROCEDURAL PERIOD. CARVEDILOL HAD ALREADY BEEN INITIATED, BUT THE DOSE WAS RELATIVELY LOW (5 MG/D). MORE AGGRESSIVE BLOOD PRESSURE TITRATION MIGHT REDUCE RUPTURE RISK. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: A 3.5-MM OPEN IRRIGATED CATHETER (THERMOCOOL SMARTTOUCH SURROUND FLOW; BIOSENSE WEBSTER, IRVINE, CA). OTHER BWI PRODUCTS: NONE. NON-BWI DEVICES: NONE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 PATIENT OF AN 84-YEAR-OLD MALE, DEVELOPED SUDDEN-ONSET HYPOTENSION FOLLOWING DEFECATION. URGENT LEFT VENTRICULOGRAPHY REVEALED A RUPTURE OF THE LV INFERIOR WALL AT THE ABLATION SITE (FIGURE 2B; VIDEO 1 , VIEW VIDEO ONLINE). DESPITE EMERGENCY SURGICAL REPAIR, THE PATIENT DIED WITHIN 2 HOURS POST-PROCEDURE. ALTHOUGH LV RUPTURE FOLLOWING RFCA HAS BEEN PREVIOUSLY REPORTED TO OUR KNOWLEDGE, THIS IS THE FIRST DOCUMENTED CASE OF ¿DELAYED¿ LV RUPTURE FOLLOWING RFCA. THE RUPTURE WAS LIKELY CAUSED BY LOCALIZED MYOCARDIAL INJURY FROM RADIOFREQUENCY ENERGY, WHICH WEAKENED THE TISSUE AT THE ABLATION SITE. ADDITIONALLY, INCREASED INTRACARDIAC PRESSURE DUE TO STRAINING DURING DEFECATION, COMBINED WITH PRESERVED LV FUNCTION (EJECTION FRACTION: 64%), MAY HAVE CONTRIBUTED TO THIS FATAL EVENT. LV RUPTURE AFTER RFCA HAS BEEN PRIMARILY ASSOCIATED WITH CASES WHERE STEAM POPS OCCUR, WHICH ARE OFTEN ACCOMPANIED BY ABRUPT IMPEDANCE RISES. IN THIS CASE, ALTHOUGH IMPEDANCE DID NOT EXCEED BASELINE VALUES, TRANSIENT RISES WERE OBSERVED DURING APPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1828137 | THERMOCOOL SMARTTOUCH SF | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male | Required Intervention| L| D |