BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 14710599 · Received June 16, 2022

    Report

    Report Number
    2029046-2022-01333
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    February 2, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: THIYAGARAJAH A, MAHAJAN R, IWAI S, GUPTA A, LINZ D, CHIM I, EMAMI M, KADHIM K, O'SHEA C, MIDDELDORP ME, LAU DH, SANDERS P. SINGLE RING ISOLATION FOR ATRIAL FIBRILLATION ABLATION: IMPACT OF THE LEARNING CURVE. J CARDIOVASC ELECTROPHYSIOL. 2022 APR;33(4):608-617. DOI: 10.1111/JCE.15387. EPUB 2022 FEB 2. PMID: 35077605. 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. 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: THIYAGARAJAH A, MAHAJAN R, IWAI S, GUPTA A, LINZ D, CHIM I, EMAMI M, KADHIM K, O'SHEA C, MIDDELDORP ME, LAU DH, SANDERS P. SINGLE RING ISOLATION FOR ATRIAL FIBRILLATION ABLATION: IMPACT OF THE LEARNING CURVE. J CARDIOVASC ELECTROPHYSIOL. 2022 APR;33(4):608-617. DOI: 10.1111/JCE.15387. EPUB 2022 FEB 2. PMID: 35077605. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: ALTHOUGH SINGLE RING ISOLATION IS AN ACCEPTED STRATEGY FOR UNDERTAKING PULMONARY VEIN (PV) AND POSTERIOR WALL ISOLATION (PWI) DURING ATRIAL FIBRILLATION (AF) ABLATION, THE LEARNING CURVE ASSOCIATED WITH THIS TECHNIQUE AS WELL AS PROCEDURAL AND CLINICAL SUCCESS RATES HAVE NOT BEEN WIDELY REPORTED. METHODS AND RESULTS: PROSPECTIVELY COLLECTED DATA FROM 250 CONSECUTIVE PATIENTS UNDERGOING DE NOVO AF ABLATION USING SINGLE RING ISOLATION. PWI WAS ACHIEVED IN 212 PATIENTS (84.8%) AND PV ISOLATION WITHOUT PWI WAS ACHIEVED IN 37 PATIENTS (14.4%). THIRTY-ONE CASES (12.4%) DEMONSTRATED INFERIOR LINE SPARING WHERE PWI WAS ACHIEVED WITHOUT A CONTINUOUS POSTERIOR WALL INFERIOR LINE. A LEARNING CURVE WAS OBSERVED, WITH HIGHER RATES OF PWI (98% LAST 50 VS. 82% FIRST 50 CASES, P = .016), HIGHER RATES OF INFERIOR LINE SPARING (20% LAST 50 VS. 8% FIRST 50 CASES, P = .071) AND LOWER ABLATION TIMES (43.8 MIN (INTERQUARTILE RANGE [IQR]: 34.6¿57.0 MIN) LAST 50 VERSUS. 96.5 MIN (IQR: 80.8¿115.8 MIN) FIRST 50 CASES; P < .001). THREE (1.3%) MAJOR PROCEDURE-RELATED COMPLICATIONS WERE OBSERVED. TWELVE-MONTH, SINGLE-PROCEDURE FREEDOM FROM ATRIAL ARRHYTHMIA WITHOUT DRUGS WAS 70.5% (95% CONFIDENCE INTERVAL [CI]: 61.5%¿77.7%) AND 60.0% (95% CI: 50.2%¿68.4%) FOR PAROXYSMAL AND PERSISTENT/ LONGSTANDING PERSISTENT AF. TWELVE-MONTH MULTI-PROCEDURE FREEDOM FROM ATRIAL ARRHYTHMIA WAS 92.2% (95%CI: 85.6%¿95.9%) AND 85.6% (95%CI: 77.2%¿91.0%) FOR PAROXYSMAL AND PERSISTENT/LONGSTANDING PERSISTENT AF. CONCLUSION: EMPLOYING A SINGLE RING ISOLATION APPROACH, PWI CAN BE ACHIEVED IN MOST CASES. THERE IS A SUBSTANTIAL LEARNING CURVE WITH HIGHER RATES OF PWI, REDUCED ABLATION TIMES, AND HIGHER RATES OF INFERIOR LINE SPARING AS PROCEDURAL EXPERIENCE GROWS. LONG-TERM FREEDOM FROM ARRHYTHMIA IS COMPARABLE TO OTHER AF ABLATION TECHNIQUES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH, BIOSENSE-WEBSTER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO®3 SYSTEM -LASSO CATHETER, BIOSENSE-WEBSTER. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ENSITE PRECISION CARDIAC MAPPING SYSTEM. SLO SHEATH. BRK1. D/F FLEXIBILITY. TACTISENSE, ABBOTT MEDICAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THREE ADVERSE EVENTS WERE REPORTED IN THIS LITERATURE COMPLAINT: TWO PATIENTS DEVELOPED LARGE PERICARDIAL EFFUSIONS REQUIRING DRAINAGE. ONE PATIENT WHO DEVELOPED SINUS ARREST FOLLOWING TERMINATION OF PERSISTENT AF REQUIRING IMPLANTATION OF A PERMANENT PACEMAKER. (HEART BLOCK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132500 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R BRK1| D/F FLEXABILITY| ENSITE PRECISION CARDIAC MAPPING SYSTEM| SLO SHEATH| TACTISENSE, ABBOTT MEDICAL| UNK_CARTO 3| UNK_LASSO