BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 16573265 · Received March 20, 2023

    Report

    Report Number
    2029046-2023-00578
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    November 29, 2022
    Report Date
    March 20, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:DI BIASE L, TABEREAUX P, LIU CF, VASAIWALA S, CHUGH A, SALIBA WI; SURPOINT POSTAPPROVAL TRIAL INVESTIGATORS. REPRODUCIBILITY OF PAROXYSMAL ATRIAL FIBRILLATION ABLATION CLINICAL OUTCOMES USING COMPOSITE ABLATION INDEX WITH DIFFERENT CONTACT FORCE-SENSING CATHETERS. CIRC ARRHYTHM ELECTROPHYSIOL. 2022 DEC;15(12):E011561. DOI: 10.1161/CIRCEP.122.011561. EPUB 2022 NOV 29. PMID: 36445824. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT 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. CATALOG SHOULD BE UNK_SMART TOUCH BIDIRECTIONAL SF.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:DI BIASE L, TABEREAUX P, LIU CF, VASAIWALA S, CHUGH A, SALIBA WI; SURPOINT POSTAPPROVAL TRIAL INVESTIGATORS. REPRODUCIBILITY OF PAROXYSMAL ATRIAL FIBRILLATION ABLATION CLINICAL OUTCOMES USING COMPOSITE ABLATION INDEX WITH DIFFERENT CONTACT FORCE-SENSING CATHETERS. CIRC ARRHYTHM ELECTROPHYSIOL. 2022 DEC;15(12):E011561. DOI: 10.1161/CIRCEP.122.011561. EPUB 2022 NOV 29. PMID: 36445824. OBJECTIVE/METHODS/STUDY DATA: US TRIAL INCLUDED PATIENTS TREATED WITH STSF. FIFTY PATIENTS WERE ENROLLED IN THE ST PATIENT COHORT BETWEEN APRIL 2019 AND JUNE 2020. ONE PATIENT WITHDREW FROM THE STUDY; THEREFORE, 49 PATIENTS WERE INCLUDED IN THE SAFETY AND THE EFFECTIVENESS POPULATIONS. BASELINE PATIENT CHARACTERISTICS WERE SIMILAR TO THAT OF THE STSF PATIENT COHORT WITH MEAN AGE OF 62.7 YEARS, 55.1% FEMALE, AND MEAN CHA2DS2-VASC SCORE OF 1.9.3 SYMPTOMATIC ATRIAL FIBRILLATION DURATION WAS SLIGHTLY LOWER FOR THE ST COHORT AT 31 MONTHS VERSUS 37 MONTHS IN THE STSF GROUP.3. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED NAMED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS:SMARTTOUCH SF. OTHER NAMED BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (POSSIBLY ASSOCIATED WITH THE SUSPECTED DEVICE): QTY 2 STROKE/CEREBROVASCULAR ACCIDENT (ONE DISCHARGED 6 DAYS POST INDEX ABLATION AND NO NEURLOGICAL DEFICITS AT 85 DAY FOLLOW UP AND THE OTHER DISCHARCHED 2 DAYS POST ABLATION WITH SIGNS OF FULL RECOVERY. QTY 1 PERICARDITIS (INTERVENTION NOT DISCUSSED FOR THIS PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713925 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L