BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19751059 · Received July 16, 2024

    Report

    Report Number
    2029046-2024-02370
    Event Type
    Injury
    Date Received
    July 16, 2024
    Report Date
    July 16, 2024
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SAYURI TOKIOKA1 ; SEIJI FUKAMIZU1 ; TAKASHI KIMURA1 ; MASAO TAKAHASHI1 ; TAKESHI KITAMURA1 ; RINTARO HOJO1 (2022). ASSOCIATION BETWEEN INTRA-BOX ABLATION DURING POSTERIOR WALL ISOLATION FOR PERSISTENT ATRIAL FIBRILLATION AND POSTERIOR WALL RECONNECTION. JOURNAL OF ATRIAL FIBRILLATION & ELECTROPHYSIOLOGY. 15 (1). 10.4022/JAFIB.20200442. D4: UDI: AS THE CATALOG/MODEL AND LOT NUMBERS WERE NOT PROVIDED, THE (01)GTIN IS 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: SAYURI TOKIOKA1 ; SEIJI FUKAMIZU1 ; TAKASHI KIMURA1 ; MASAO TAKAHASHI1 ; TAKESHI KITAMURA1 ; RINTARO HOJO1 (2022). ASSOCIATION BETWEEN INTRA-BOX ABLATION DURING POSTERIOR WALL ISOLATION FOR PERSISTENT ATRIAL FIBRILLATION AND POSTERIOR WALL RECONNECTION. JOURNAL OF ATRIAL FIBRILLATION & ELECTROPHYSIOLOGY. 15 (1). 10.4022/JAFIB.20200442. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: POSTERIOR WALL ISOLATION (PWI) COMBINED WITH PULMONARY VEIN ISOLATION (PVI) HAS BEEN PROVEN EFFECTIVE FOR PERSISTENT ATRIAL FIBRILLATION (AF). INTRA-BOX ABLATION, DEFINED AS APPLICATION IN THE ¿BOX¿ AREA DURING PWI IN THIS STUDY, IS SOMETIMES NECESSARY WHEN LINEAR ABLATION OF THE ROOF AND BOTTOM FAILS TO ACHIEVE COMPLETE ISOLATION. THIS STUDY AIMED TO INVESTIGATE THE FACTORS OF PATIENTS REQUIRING INTRA-BOX ABLATION AND TO EVALUATE THE EFFECT OF INTRA-BOX ABLATION ON CLINICAL OUTCOMES. METHODS: THIS IS AN OBSERVATIONAL STUDY INCLUDING PATIENTS WHO UNDERWENT PVI AND PWI FOR PERSISTENT AF IN THE FIRST PROCEDURE FROM JUNE 2017 AND MARCH 2020, AT THE TOKYO METROPOLITAN HIROO HOSPITAL. WHEN LINEAR ABLATION OF THE ROOF AND BOTTOM FAILED TO COMPLETE PWI, INTRABOX ABLATION WAS ADDED. SIX MONTHS AFTER THE PROCEDURE, PATIENTS UNDERTOOK FOLLOW-UP ELECTROPHYSIOLOGICAL STUDY AND ADDITIONAL ABLATION AS THE SECOND PROCEDURE. FINDINGS OF THE LEFT ATRIUM (LA) MAPPING AND ABLATION IN THE FIRST PROCEDURE AND POSTERIOR WALL (PW) RECONNECTION IN THE SECOND PROCEDURE WERE EVALUATED. PATIENT CHARACTERISTICS AND OUTCOMES WERE COMPARED BETWEEN PATIENTS WITH AND WITHOUT INTRA-BOX ABLATION. RESULTS: OF THE 93 PATIENTS INCLUDED IN THIS STUDY, SUCCESSFUL PWI WAS ACHIEVED IN 91 (MEAN AGE, 67.5±9.8 YEARS; MALE, 75.3%), AND INTRA-BOX ABLATION WAS NEEDED IN 59 (63.4%). SHORTER PW ACTIVATION TIME (40.3±10.4 VS 51.3±15.2, P=0.026) AND LARGER UPWARD CONDUCTION PATTERNS IN THE PW WERE SIGNIFICANT ASSOCIATION WITH THE NECESSITY OF INTRA-BOX ABLATION. MORE PW RECONNECTION IN THE SECOND PROCEDURE WAS OBSERVED IN PATIENTS WITH INTRA-BOX ABLATION THAN IN THOSE WITHOUT INTRA-BOX ABLATION (21/28,75.0% VS 8/20, 40.0%; P=0.020). CONCLUSION: WE SHOWED THAT THE REQUIREMENT OF INTRA-BOX ABLATION WAS RELATED TO LOWER DURABILITY OF PW. FINDINGS OF LA MAPPING SUGGESTED THE POSSIBILITY THAT PW CONDUCTION VELOCITY AND PATTERNS WAS ONE OF THE MECHANISMS OF FAILURE OF LINEAR PWI. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMART TOUCH SF. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: PENTARAY, CARTO, LASSO. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BEEAT (JAPAN LIFELINE, TOKYO, JAPAN) OR INQUIRY (ABBOTT, ABBOTT PARK, ILLI, USA), CIRC-S-CATH (CIRCA SCIENTIFIC, ENGLEWOOD, CO, USA). OF NOTE, THE HEMATOMAS ARE ASSOCIATED WITH THE SHEATH USED FOR VASCULAR ACCESS, WHICH WAS NOT SPECIFIED IN THE ARTICLE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMART TOUCH SF: QTY 1 ¿ (PULMONARY VEIN STENOSIS)(RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738966 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 BEEAT (JAPAN LIFELINE)| CARTO| CIRC-S-CATH (CIRCA SCIENTIFIC)| INQUIRY (ABBOTT)| LASSO| PENTARAY