THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

Report

Report Number: 2029046-2024-02352
Event Type: Injury
Date Received: July 12, 2024
Date of Event: December 28, 2022
Report Date: July 12, 2024
Manufacturer: BIOSENSE WEBSTER INC
Product Code: LPB
PMA / PMN Number: P030031
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
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: EGAMI Y, NISHINO M, NOHARA H, KAWANAMI S, SUGAE H, UKITA K, KAWAMURA A, NAKAMURA H, YASUMOTO K, TSUDA M, OKAMOTO N, MATSUNAGA-LEE Y, YANO M, TANOUCHI J. COMPARISON OF ADVANCED GENERATION CRYOBALLOON ABLATION AND ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION WITH NON-PULMONARY VEIN TRIGGER INDUCTION TEST AND ADDITIONAL ABLATION IN PAROXYSMAL ATRIAL FIBRILLATION. J INTERV CARD ELECTROPHYSIOL. 2023 OCT;66(7):1571-1580. DOI: 10.1007/S10840-022-01459-8. EPUB 2022 DEC 28. PMID: 36575227. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. 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).

Description of Event or Problem · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: EGAMI Y, NISHINO M, NOHARA H, KAWANAMI S, SUGAE H, UKITA K, KAWAMURA A, NAKAMURA H, YASUMOTO K, TSUDA M, OKAMOTO N, MATSUNAGA-LEE Y, YANO M, TANOUCHI J. COMPARISON OF ADVANCED GENERATION CRYOBALLOON ABLATION AND ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION WITH NON-PULMONARY VEIN TRIGGER INDUCTION TEST AND ADDITIONAL ABLATION IN PAROXYSMAL ATRIAL FIBRILLATION. J INTERV CARD ELECTROPHYSIOL. 2023 OCT;66(7):1571-1580. DOI: 10.1007/S10840-022-01459-8. EPUB 2022 DEC 28. PMID: 36575227. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: AN ABLATION INDEX (AI)-GUIDED PULMONARY VEIN ISOLATION (PVI) OR 2ND GENERATION CRYOBALLOON (CB)-PVI HAS BEEN SHOWN TO REDUCE THE ATRIAL FIBRILLATION (AF) BURDEN BY 99% DESPITE THE ABSENCE OF ABLATION OF NON-PULMONARY VEIN (PV) TRIGGERS IN PATIENTS WITH PAROXYSMAL AF. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE EFFECTS OF PVI ALONE STRATEGY USING 2ND GENERATION CB COMPARED WITH AI-GUIDED PVI WITH AN ADDITIONAL INDUCTION TEST AND SUBSEQUENT AF TRIGGER ABLATION. METHODS AND RESULTS: WE INVESTIGATED 223 PATIENTS WITH SYMPTOMATIC PAROXYSMAL AF WHO UNDERWENT AN INITIAL PVI BETWEEN AUGUST 2018 AND AUGUST 2020. THE STUDY PATIENTS WERE DIVIDED INTO 2 GROUPS: CB-PVI WITHOUT AN INDUCTION TEST (CB-PVI ALONE GROUP, N = 82) AND AI-GUIDED PVI WITH AN INDUCTION TEST AND SUBSEQUENT ADDITIONAL ABLATION OF NON-PV TRIGGERS (AI-PVI PLUS GROUP, N = 141). IN THE AI-PVI PLUS GROUP, A TOTAL OF 62 NON-PV TRIGGERS WERE INDUCED IN 38 PATIENTS, AND NON-PV TRIGGERS IN 22 PATIENTS WERE COMPLETELY ABLATED. THE PROCEDURE TIME AND LEFT ATRIUM DWELL TIME WERE SIGNIFICANTLY SHORTER IN THE CB-PVI ALONE GROUP THAN AI-PVI PLUS GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF PROCEDURAL COMPLICATIONS BETWEEN THE 2 GROUPS (P = 0.650). THE AF FREE SURVIVAL RATE IN THE CB-PVI ALONE GROUP AND AI-PVI PLUS GROUP WAS 80% VS. 80% AT 24 MONTHS (P = 0.969). CONCLUSIONS: AN PVI ALONE STRATEGY USING ADVANCED GENERATION CB DID NOT DIFFER IN THE CLINICAL OUTCOMES COMPARED WITH AN AI-GUIDED PVI STRATEGY WITH AN INDUCTION TEST AND SUBSEQUENT ABLATION OF NON-PV TRIGGERS IN THE PATIENTS WITH PAROXYSMAL AF. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: PENTARAY, CARTO3 SYSTEM CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CIRCULAR MAPPING CATHETER (MEDTRONIC), 8.5-FR SHEATH (ST. JUDE MEDICAL) VASCULAR COMPLICATIONS LIKE INGUINAL PSEUDOANEURYSM WAS REPORTED IN THE ARTICLE, BUT A NON-BWI SHEATH WAS USED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF: QTY 3: THREE PATIENTS EXPERIENCED TRANSIENT PHRENIC NERVE PALSY (DIAPHRAGMATIC PARALYSIS), WHICH RESOLVED WITHIN 6 MONTHS IN 1 PATIENT AND WITHIN 12 MONTHS IN 2 PATIENTS. (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT) QTY 1: A PATIENT EXPERIENCED ACUTE GASTRIC HYPOMOTILITY (GASTROPARESIS), WHICH IMPROVED AFTER 10 DAYS OF FASTING, DECOMPRESSION WITH NASAL-GASTRIC TUBE, AND ADMINISTRATION OF MOSAPRIDE. (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT) QTY 1: (PNEUMOTHORAX) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
861332	THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER	CARDIAC ABLATION PERCUTANEOUS CATHETER	LPB	BIOSENSE WEBSTER INC

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other	8.5-FR SHEATH (ST. JUDE MEDICAL)\| CIRCULAR MAPPING CATHETER (MEDTRONIC)\| UNK_CARTO 3\| UNK_PENTARAY NAV ECO