BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 14703013 · Received June 15, 2022

    Report

    Report Number
    2029046-2022-01325
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    March 28, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: NAKASHIMA T, PAMBRUN T, VLACHOS K, GOUJEAU C, ANDRÉ C, KRISAI P, RAMIREZ FD, PINTICAN G, KAMAKURA T, TAKAGI T, NAKATANI Y, SURGET E, CHENITI G, TIXIER R, CHAUVEL R, DUCHATEAU J, SACHER F, COCHET H, HOCINI M, HAÏSSAGUERRE M, JAÏS P, DERVAL N. STRATEGY FOR REPEAT PROCEDURES IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION: SYSTEMATIC LINEAR ABLATION WITH ADJUNCTIVE ETHANOL INFUSION INTO THE VEIN OF MARSHALL VERSUS ELECTROPHYSIOLOGY-GUIDED ABLATION. J CARDIOVASC ELECTROPHYSIOL. 2022 MAR 28. DOI: 10.1111/JCE.15472. EPUB AHEAD OF PRINT. PMID: 35347799. 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 4. 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. THE LITERATURE FILE IS TOO LARGE TO ATTACH. 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: NAKASHIMA T, PAMBRUN T, VLACHOS K, GOUJEAU C, ANDRÉ C, KRISAI P, RAMIREZ FD, PINTICAN G, KAMAKURA T, TAKAGI T, NAKATANI Y, SURGET E, CHENITI G, TIXIER R, CHAUVEL R, DUCHATEAU J, SACHER F, COCHET H, HOCINI M, HAÏSSAGUERRE M, JAÏS P, DERVAL N. STRATEGY FOR REPEAT PROCEDURES IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION: SYSTEMATIC LINEAR ABLATION WITH ADJUNCTIVE ETHANOL INFUSION INTO THE VEIN OF MARSHALL VERSUS ELECTROPHYSIOLOGY-GUIDED ABLATION. J CARDIOVASC ELECTROPHYSIOL. 2022 MAR 28. DOI: 10.1111/JCE.15472. EPUB AHEAD OF PRINT. PMID: 35347799. OBJECTIVE/METHODS/STUDY DATA: -INTRODUCTION: THE OPTIMAL STRATEGY AFTER A FAILED ABLATION FOR PERSISTENT ATRIAL FIBRILLATION (PERAF) IS UNKNOWN. THIS STUDY EVALUATED THE VALUE OF AN ANATOMICALLY GUIDED STRATEGY USING A SYSTEMATIC SET OF LINEAR LESIONS WITH ADJUNCTIVE ETHANOL INFUSION INTO THE VEIN OF MARSHALL (ET-VOM) IN PATIENTS REFERRED FOR SECOND PERAF ABLATION PROCEDURES. -METHODS AND RESULTS: PATIENTS WITH PERAF WHO UNDERWENT A SECOND PROCEDURE WERE GROUPED ACCORDING TO THE TWO STRATEGIES. THE FIRST STRATEGY WAS AN ANATOMICALLY GUIDED APPROACH USING SYSTEMATIC LINEAR ABLATION WITH ADJUNCTIVE ET-VOM, WITH BIDIRECTIONAL BLOCKS AT THE POSTERIOR MITRAL ISTHMUS (MI), ROOF, AND CAVOTRICUSPID ISTHMUS (CTI) AS THE PROCEDURAL ENDPOINT (GROUP I). THE SECOND ONE WAS AN ELECTROPHYSIOLOGY-GUIDED STRATEGY, WITH ATRIAL TACHYARRHYTHMIA TERMINATION AS THE PROCEDURAL ENDPOINT (GROUP II). ARRHYTHMIA BEHAVIOR DURING THE PROCEDURE GUIDED THE ABLATION STRATEGY. GROUPS I AND II CONSISTED OF 96 PATIENTS (65 ± 9 YEARS; 71 MEN) AND 102 PATIENTS (63 ± 10 YEARS; 83 MEN), RESPECTIVELY. BASELINE CHARACTERISTICS WERE COMPARABLE. IN GROUP I, ET-VOM WAS SUCCESSFULLY PERFORMED IN 91/96 (95%), AND PROCEDURAL ENDPOINT (BIDIRECTIONAL BLOCK ACROSS ALL THREE ANATOMICAL LINES) WAS ACHIEVED IN 89/96 (93%). IN GROUP II, PROCEDURAL ENDPOINT (ATRIAL TACHYARRHYTHMIA TERMINATION) WAS ACHIEVED IN 80/102 (78%). ONE-YEAR FOLLOW-UP DEMONSTRATED GROUP I (21/96 [22%]) EXPERIENCED LESS RECURRENCE COMPARED TO GROUP II (38/102 [37%], LOG-RANK P = .01). THIS WAS DRIVEN BY LOWER AT RECURRENCE IN GROUP I (GROUP I: 10/96 [10%] VS. GROUP II: 29/102 [28%]; P = .002). -CONCLUSION: ANATOMICALLY GUIDED STRATEGY WITH ADJUNCTIVE ET-VOM IS SUPERIOR TO AN ELECTROPHYSIOLOGY-GUIDED STRATEGY FOR SECOND PROCEDURES IN PATIENTS WITH PERAF AT 1-YEAR FOLLOW-UP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF OR THERMOCOOL SF; BIOSENSE WEBSTER. OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: AGILI NXT;S¿ ABBOTT. A DECAPOLAR CATHETER. RHYTHMIA (BOSTON SCIENTIFIC CORPORATION). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THERE WERE TWO REPORTED ADVERSE EVENTS IN THIS LITERATURE ARTICLE: CARDIAC TAMPONADE. STROKE. THERE WAS NO MENTION OF INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208270 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening A DECAPOLAR CATHETER| AGILI NXT,S¿ ABBOTT| CARTO3| RHYTHMIA (BOSTON SCIENTIFIC CORPORATION).