BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 15315980 · Received August 29, 2022

    Report

    Report Number
    2029046-2022-02026
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SCHMIDT B, BORDIGNON S, TOHOKU S, CHEN S, BOLOGNA F, URBANEK L, PANSERA F, ERNST M, CHUN KRJ. 5S STUDY: SAFE AND SIMPLE SINGLE SHOT PULMONARY VEIN ISOLATION WITH PULSED FIELD ABLATION USING SEDATION. CIRC ARRHYTHM ELECTROPHYSIOL. 2022 JUN;15(6):E010817. DOI: 10.1161/CIRCEP.121.010817. EPUB 2022 MAY 26. PMID: 35617232. 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 THE 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SCHMIDT B, BORDIGNON S, TOHOKU S, CHEN S, BOLOGNA F, URBANEK L, PANSERA F, ERNST M, CHUN KRJ. 5S STUDY: SAFE AND SIMPLE SINGLE SHOT PULMONARY VEIN ISOLATION WITH PULSED FIELD ABLATION USING SEDATION. CIRC ARRHYTHM ELECTROPHYSIOL. 2022 JUN;15(6):E010817. DOI: 10.1161/CIRCEP.121.010817. EPUB 2022 MAY 26. PMID: 35617232. OBJECTIVE/METHODS/STUDY DATA: . THE AIM OF THE STUDY WAS TO DESCRIBE THE ADOPTION AND THE PROCESS OF STREAMLINING PROCEDURES WITH A NEW ABLATION TECHNOLOGY OF PULSED FIELD ABLATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CIRCULAR MAPPING CATHETER (PRESUMED TO BE LASSO) USED FOR THE VALIDATION PHASE. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: FARADRIVE SHEATH, FARAWAVE ABLATION CATHETER (FARAPULSE). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (WITHIN THE VALIDATION PHASE AND POSSIBLY ASSOCIATED WITH THE CIRCULAR MAPPING CATHETER): PATIENT NUMBER 11 EXPERIENCED STROKE WITH BLURRED VISION 12 HOURS AFTER PROCEDURE. AFTER 4 WEEKS, LOSS OF VISION HAD NORMALIZED. PATIENT NUMBER 16 EXPERIENCED STROKE WITH WEAKNESS OF THE RIGHT HAND AND GAIT ATAXIA MORNING AFTER THE PROCEDURE. SYMPTOMS RESOLVED DURING FOLLOW UP VISIT AT 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269446 UNK_LASSO CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening FARADRIVE SHEATH| FARAWAVE ABLATION CATHETER (FARAPULSE)