THERMOCOOL SMARTTOUCH SF

Report

Report Number: 2029046-2026-01190
Event Type: Injury
Date Received: April 13, 2026
Date of Event: January 10, 2026
Report Date: April 13, 2026
Manufacturer: BIOSENSE WEBSTER INC
Product Code: LPB
PMA / PMN Number: P030031/S078
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TAIGEN TL, NAIR DG, SHARMA D, KIEHL EL, OSORIO J, NEUZIL P, KAUTZNER J, MOUNTANTONAKIS SE, NATALE A, HUMMEL JD, DOSHI SK, AMIN AK, SIDDIQUI UR, VAN BRAGT KA, CERKVENIK J, TARAKJI KG, REDDY VY, MANSOUR M, ANTER E, SAME DAY DISCHARGE CAN BE PERFORMED SAFELY AFTER ATRIAL FIBRILLATION CATHETER ABLATION USING A WIDE-FOOTPRINT LATTICE-TIP DUAL-ENERGY SYSTEM, HEART RHYTHM O2 (2026), DOI: HTTPS://DOI.ORG/10.1016/J.HROO.2026.01.015. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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).

Description of Event or Problem · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TAIGEN TL, NAIR DG, SHARMA D, KIEHL EL, OSORIO J, NEUZIL P, KAUTZNER J, MOUNTANTONAKIS SE, NATALE A, HUMMEL JD, DOSHI SK, AMIN AK, SIDDIQUI UR, VAN BRAGT KA, CERKVENIK J, TARAKJI KG, REDDY VY, MANSOUR M, ANTER E, SAME DAY DISCHARGE CAN BE PERFORMED SAFELY AFTER ATRIAL FIBRILLATION CATHETER ABLATION USING A WIDE-FOOTPRINT LATTICE-TIP DUAL-ENERGY SYSTEM, HEART RHYTHM O2 (2026), DOI: HTTPS://DOI.ORG/10.1016/J.HROO.2026.01.015. BACKGROUND: SAME DAY DISCHARGE (SDD) AFTER ATRIAL FIBRILLATION (AF) ABLATION IS GENERALLY CONSIDERED SAFE, SINCE MOST COMPLICATIONS ARE IDENTIFIED DURING (OR IMMEDIATELY) AFTER THE PROCEDURE. OBJECTIVE: THE AIM OF THIS STUDY IS TO EVALUATE SDD IN THE SPHERE PER-AF TRIAL. METHODS: THE SPHERE PER-AF TRIAL (NCT05120193) WAS A MULTICENTER, RANDOMIZED, SINGLE-BLIND, CONTROLLED TRIAL IN PATIENTS WITH PERSISTENT AF (PERAF). THE TRIAL WAS DESIGNED TO TEST NON INFERIORITY IN SAFETY AND EFFECTIVENESS OF THE DUAL-ENERGY (RADIOFREQUENCY (RF)/ PULSED FIELD (PF)), WIDE-FOOTPRINT (9 MM), LATTICE-TIP CATHETER (SPHERE-9, MEDTRONIC, MN) AND MAPPING SYSTEM (AFFERA, MEDTRONIC; HEREAFTER REFERRED TO AS ¿INVESTIGATIONAL¿) COMPARED TO A CONVENTIONAL CONTACT-FORCE SENSING RF CATHETER (THERMOCOOL STSF, BIOSENSE WEBSTER, IRVINE, CA), AND COMMERCIALLY AVAILABLE MULTI-ELECTRODE MAPPING CATHETER AND MAPPING SYSTEM (CARTO 3, BIOSENCE WEBSTER; HEREAFTER REFERRED TO AS ¿CONTROL¿). ALL OPERATORS WERE EXPERIENCED USERS OF THE CONTROL ABLATION SYSTEM. THIS POST-HOC ANALYSIS EXAMINED FEASIBILITY, PROCEDURAL SAFETY, 30-DAY READMISSIONS, AND MORTALITY RATES OF SDD VS. ONS IN THE TRIAL DATA SET. ALL RANDOMIZED PATIENTS WITH DISCHARGE DATES AVAILABLE WERE INCLUDED IN THE ANALYSIS (N=211 INVESTIGATIONAL PATIENTS AND N=207 CONTROL PATIENTS). THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. CONCLUSIONS: AMONG THE TRADITIONAL THERMAL ABLATION TECHNOLOGIES, SDD PROTOCOLS HAVE BEEN WELL 326 ESTABLISHED AND SAFELY PRACTICED. HERE, SDD WAS SAFELY ACHIEVED WITH THE DUAL-ENERGY LATTICE-TIP 327 CATHETER, WITH NO SIGNIFICANT DIFFERENCES IN OUTCOME WHEN COMPARED TO CONVENTIONAL RF. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USED IN CONTROL GROUP: USED IN CONTROL GROUP: RF CATHETER (THERMOCOOL STSF, BIOSENSE WEBSTER, IRVINE, CA), OTHER BWI DEVICE(S): COMMERCIALLY AVAILABLE MULTI-ELECTRODE MAPPING CATHETER AND MAPPING SYSTEM (CARTO 3, BIOSENCE WEBSTER) NON-BWI DEVICES: USED IN INVESTIGATIONAL GROUP: LATTICE-TIP CATHETER (SPHERE-9, MEDTRONIC, MN) AND MAPPING SYSTEM (AFFERA, MEDTRONIC) -1 PATIENT IN THE INVESTIGATIONAL GROUP STAYED IN THE HOSPITAL FOR A STUDY PROTOCOL REQUIRED NEUROLOGICAL ASSESSMENT (AS PART OF A PREDEFINED IMAGING SUB-STUDY) AND 3 (1.4%) PATIENTS FROM THE INVESTIGATIONAL GROUP HAD PROLONGED HOSPITALIZATION. THIS WILL BE EXCLUDED AS THESE PATIENTS ARE FROM THE INVESTIGATIONAL GROUP WHO USED THE LATTICE-TIP CATHETER (SPHERE-9, MEDTRONIC, MN) AND MAPPING SYSTEM (AFFERA, MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: HYPOXIA (PROLONGED STAY TO DAY 4); INTERVENTION WAS NOT DISCUSSED. QTY 1: ESOPHAGEAL MUCOSA ERYTHEMA (OVERNIGHT STAY); INTERVENTION WAS NOT DISCUSSED. QTY 1: PERICARDITIS (REHOSPITALIZED DAYS 2-3); INTERVENTION WAS NOT DISCUSSED. QTY 1: PLEURITIC PAIN (REHOSPITALIZED DAYS 2-3); INTERVENTION WAS NOT DISCUSSED. QTY 1: HYPERVOLEMIA (REHOSPITALIZED DAYS 3-7); INTERVENTION WAS NOT DISCUSSED. QTY 1: SEPSIS (REHOSPITALIZED DAYS 5-8); INTERVENTION WAS NOT DISCUSSED. QTY 1: MYOCARDIAL INFARCTION (REHOSPITALIZED DAYS 9-11 DAYS); INTERVENTION WAS NOT DISCUSSED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
915015	THERMOCOOL SMARTTOUCH SF	CARDIAC ABLATION PERCUTANEOUS CATHETER	LPB	BIOSENSE WEBSTER INC

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Life Threatening\| H