BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18927483 · Received March 18, 2024

    Report

    Report Number
    2029046-2024-00900
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    January 4, 2024
    Report Date
    March 18, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. CATALOG: UNK_SMART TOUCH BIDIRECTIONAL SF. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SANDERS D, DU-FAY-DE-LAVALLAZ JM, WINTERFIELD J, SANTANGELI P, LIANG J, RHODES P, RAVI V, BADERTSCHER P, MAZUR A, LARSEN T, SHARMA PS, HUANG HD. SURPOINT ALGORITHM FOR IMPROVED GUIDANCE OF ABLATION FOR VENTRICULAR TACHYCARDIA (SURFIRE-VT): A PILOT STUDY. J CARDIOVASC ELECTROPHYSIOL. 2024 JAN 4. DOI: 10.1111/JCE.16165. EPUB AHEAD OF PRINT. PMID: 38174841. 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: SANDERS D, DU-FAY-DE-LAVALLAZ JM, WINTERFIELD J, SANTANGELI P, LIANG J, RHODES P, RAVI V, BADERTSCHER P, MAZUR A, LARSEN T, SHARMA PS, HUANG HD. SURPOINT ALGORITHM FOR IMPROVED GUIDANCE OF ABLATION FOR VENTRICULAR TACHYCARDIA (SURFIRE-VT): A PILOT STUDY. J CARDIOVASC ELECTROPHYSIOL. 2024 JAN 4. DOI: 10.1111/JCE.16165. EPUB AHEAD OF PRINT. PMID: 38174841. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: THE UTILITY OF ABLATION INDEX (AI) TO GUIDE VENTRICULAR TACHYCARDIA (VT) ABLATION IN PATIENTS WITH STRUCTURAL HEART DISEASE IS UNKNOWN. THE AIM OF THIS STUDY WAS TO ASSESS PROCEDURAL CHARACTERISTICS AND CLINICAL OUTCOMES ACHIEVED USING AI-GUIDED STRATEGY (TARGET VALUE 550) OR CONVENTIONAL NON-AI-GUIDED PARAMETERS IN PATIENTS UNDERGOING SCAR-RELATED VT ABLATION. METHODS: CONSECUTIVE PATIENTS (N = 103) UNDERGOING INITIAL VT ABLATION AT A SINGLE CENTER FROM 2017 TO 2022 WERE EVALUATED. PATIENT GROUPS WERE 1:1 PROPENSITY-MATCHED FOR BASELINE CHARACTERISTICS. SINGLE LESION CHARACTERISTICS FOR ALL 4707 LESIONS IN THE MATCHED COHORT (N = 74) WERE ANALYZED. THE IMPACT OF ABLATION CHARACTERISTICS WAS ASSESSED BY LINEAR REGRESSION AND CLINICAL OUTCOMES WERE EVALUATED BY COX PROPORTIONAL HAZARD MODEL. RESULTS: AFTER PROPENSITY-MATCHING, BASELINE CHARACTERISTICS WERE WELL-BALANCED BETWEEN AI (N = 37) AND NON-AI (N = 37) GROUPS. LESION SETS WERE SIMILAR (SCAR HOMOGENIZATION [41% VS. 27%; P = .34], SCAR DECHANNELING [19% VS. 8%; P = .18], CORE ISOLATION [5% VS. 11%; P = .4], LINEAR AND ELIMINATION LATE POTENTIALS/LOCAL ABNORMAL VENTRICULAR ACTIVITIES [35% VS. 44%; P = .48], EPICARDIAL MAPPING/ABLATION [11% VS. 14%; P = .73]). AI-GUIDED STRATEGY HAD 21% LOWER PROCEDURE DURATION (-47.27 MIN, 95% CONFIDENCE INTERVAL [CI] [-81.613, -12.928]; P = .008), 49% LOWER RADIOFREQUENCY TIME PER LESION (-13.707 S, 95% CI [-17.86, -9.555]; P < .001), 21% LOWER VOLUME OF FLUID ADMINISTERED (1664 CC [1127, 2209] VS. 2126 CC [1750, 2593]; P = .005). TOTAL RADIOFREQUENCY DURATION (-339 S [-24%], 95%CI [-776, 62]; P = .09) AND STEAM POPS (-155.6%, 95% CI [19.8%, -330.9%]; P = .08) WERE NONSIGNIFICANTLY LOWER IN THE AI GROUP. ACUTE PROCEDURAL SUCCESS (95% VS. 89%; P = .7) AND VT RECURRENCE (0.97, 95% CI [0.42-2.2]; P = .93) WERE SIMILAR FOR BOTH GROUPS. LESION ANALYSIS (N = 4707) DEMONSTRATED A PLATEAU IN THE MAGNITUDE OF IMPEDANCE DROPS ONCE REACHING AN AI OF 550-600. CONCLUSION: IN THIS PILOT STUDY, AN AI-GUIDED ABLATION STRATEGY FOR SCAR-RELATED VT RESULTED IN SHORTER PROCEDURE TIME AND AVERAGE RADIOFREQUENCY TIME PER LESION WITH SIMILAR ACUTE PROCEDURAL AND INTERMEDIATE-TERM CLINICAL OUTCOMES TO A NON-AI-GUIDED APPROACH UTILIZING TRADITIONAL ABLATION PARAMETERS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: PENTARAY MAPPING CATHETER, CARTO 3 MAPPING SYSTEM, DECANAV DIAGNOSTIC CATHETER, OPTRELL MAPPING CATHETER, SOUNDSTAR ICE CATHETER CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: VERSACROSS TRANSSEPTAL (BAYLIS MEDICAL) VASCULAR COMPLICATIONS ARE ASSOCIATED WITH SHEATHS AND THE ARTICLE DOES NOT DISCUSS/IDENTIFY SHEATHS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF ABLATION CATHETER: QTY 2 (PERICARDIAL EFFUSION) (RECOGNIZED PROCEDURAL COMPLICATION) QTY 2 (CARDIAC TAMPONADE) (RECOGNIZED PROCEDURAL COMPLICATION) QTY 2 (CARDIOGENIC SHOCK) (SERIOUS INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563266 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CARTO3 MAPPING SYSTEM| DECANAV DIAGNOSTIC CATHETER| OPTRELL MAPPING CATHETER| PENTARAY MAPPING CATHETER| SOUNDSTAR ICE CATHETER| VERSACROSS TRANSSEPTAL (BAYLIS MEDICAL)