BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 19626133 · Received June 27, 2024

    Report

    Report Number
    2029046-2024-02123
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 1, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. NO: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DANIEL R. MUSIKANTOW; CARLA PERDOMO; DEVIN CHAMBERLAIN; YURY MALYSHEV; CHI ZHANG; KELLY JIA; PAURUSH AMBESH; MARYAM SALEEM; NANA GEGECHKORI; JOSHUA LAMPERT; MOHIT K. TURAGAM; WILLIAM WHANG; SRINIVAS R. DUKKIPATI AND VIVEK Y. REDDY. (MAY 2024). PULSED FIELD ABLATION TO TREAT ATRIAL FIBRILLATION AND RELATED ARRHYTHMIAS RESEMBLING USUAL CLINICAL PRACTICE: INITIAL RESULTS OF VIRTUE. HEART RHYTHM VOL 21, PO-06-175 OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: PULSED FIELD ABLATION (PFA) TECHNOLOGIES ARE BEING STUDIED IN A NUMBER OF CLINICAL TRIALS, MANY WITH STRICT INCLUSION/ EXCLUSION CRITERIA-TYPICALLY YOUNGER PATIENTS WITH LESS COMORBIDITIES UNDERGOING DE-NOVO PVI PROCEDURES. SINCE THIS ONLY PARTLY REFLECTS REAL-WORLD CLINICAL MANAGEMENT OF AF, HEREIN, WE PRESENT THE ACUTE OUTCOMES OF VIRTUE: A SINGLE-CENTER FDA IDE (G230124) STUDY OF PFA USING AN INVESTIGATIONAL CATHETER WITH INCLUSION/EXCLUSION CRITERIA REFLECTIVE OF USUAL PRACTICE, INCLUDING REDO ABLATION PROCEDURES. METHODS: THIS SINGLE-ARM STUDY (NCT 06056557) EMPLOYED A VARIABLE-LOOP CATHETER INTEGRATED WITH A MAPPING SYSTEM (VARIPULSE/CARTO, BIOSENSE) TO TREAT DE-NOVO OR REDO AF/AFL. ALL PATIENTS HAD A CONTINUOUS ATRIAL MONITORING DEVICE (ICM, PPM, ETC), TYPICALLY FOR .4 WEEKS PRIOR TO ABLATION. MULTIELECTRODE CATHETER (PENTARAY/OCTARAY) HELPED DEFINE ATRIAL ANATOMY AND ELECTROPHYSIOLOGY. ALL PVS WERE TARGETED, AND A COMMERCIALLY AVAILABLE CONTACT FORCE IRRIGATED RF ENERGY (STSF) WAS USED AS NECESSARY. IN THE EVENT OF PROXIMITY TO THE CORONARY ARTERIES, NTG WAS ADMINISTERED AT THE DISCRETION OF THE OPERATORS. RESULTS: THIS ANALYSIS INCLUDES 125 PTS (AGE 68 6 11 YRS; F 23.2%,) PRESENTING FOR DE-NOVO AF (N554: 45 PAF, 9 PERAF), REDO AF (N550) OR ATYPICAL AFL (N531); APPLYING CRITERIA FROM A RECENT FDA PIVOTAL TRIAL (ADMIRE, NCT 05293639), ONLY 23.2% PATIENTS WOULD HAVE QUALIFIED. ABLATION BEYOND PVI WAS PERFORMED IN 80% OF PTS, AND REQUIRED A FOCAL (RFA) CATHETER IN 26% (TABLE); RF WAS USED FOR FAILURE OF PFA FOR A MI (N54) OR CTI (N53) LINES, AND USED PRIOR TO PFA FOR THE REST (CTI N517, MI N510 & NEAR CONDUCTION SYSTEM N55). TOTAL ABLATION TIME WAS 33 6 26 MIN WITH 28 6 7MIN FOR DE-NOVO PVI AND 11 6 17 MIN FOR PWI. TWO SERIOUS AES OCCURRED IN 2 PTS: 1 CVA REQUIRING THROMBECTOMY AND 1 TRANSIENT DYSARTHRIA W/ +MRI. APPLICATION: THE VARIABLE-LOOP PFA CAN TREAT A VARIETY OF AF/AFL PTS, WITH LESIONS BEYOND PVI. INADEQUATE TISSUE-CONTACT MAY LEAD TO DIFFICULTY ACHIEVING BLOCK IN CERTAIN LINEAR LESIONS, REQUIRING A FOCAL CATHETER. NEXT STEPS/FUTURE: ONE-YEAR ARRHYTHMIA OUTCOMES WILL BE DERIVED FROM CONTINUOUS MONITORING FROM IMPLANTED DEVICES LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: VARIPULSE CATHETER AND THERMOCOOL SMARTTOUCH SF CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF CATHETER: QTY 1 ¿ (CEREBROVASCULAR ACCIDENT) REQUIRING THROMBECTOMY (SURGICAL INTERVENTION) QTY 1 TRANSIENT DYSARTHRIA WITH POSITIVE MRI (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED VARIPULSE CATHETER: QTY 1 ¿ (CEREBROVASCULAR ACCIDENT) REQUIRING THROMBECTOMY (SURGICAL INTERVENTION) QTY 1 TRANSIENT DYSARTHRIA WITH POSITIVE MRI (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480722 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R