BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_QDOT MICRO

    MDR report key: 18923955 · Received March 18, 2024

    Report

    Report Number
    2029046-2024-00877
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 6, 2024
    Report Date
    March 18, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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: PELLER M, WAWRZENCZYK M, CIECIERSKI P, BALSAM P, MARCHEL M, KRZOWSKI B, MACIEJEWSKI C, MITRZAK K, GRABOWSKI M, OPOLSKI G, LODZINSKI P. GREATER DISTANCE BETWEEN ABLATION LINES REDUCES THE RECURRENCE RATE AFTER PULMONARY VEIN ISOLATION. POL ARCH INTERN MED. 2024 FEB 6:16677. DOI: 10.20452/PAMW.16677. EPUB AHEAD OF PRINT. PMID: 38324391. 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: PC-001555171 BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER PC-001555171 HAS 2 REPORTS. 1) MANUFACTURER REPORT NUMBER 2029046-2024-00877 FOR QDOT. 2) MANUFACTURER REPORT NUMBER 2029046-2024-00878 FOR THERMOCOOL SMARTTOUCH

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PELLER M, WAWRZENCZYK M, CIECIERSKI P, BALSAM P, MARCHEL M, KRZOWSKI B, MACIEJEWSKI C, MITRZAK K, GRABOWSKI M, OPOLSKI G, LODZINSKI P. GREATER DISTANCE BETWEEN ABLATION LINES REDUCES THE RECURRENCE RATE AFTER PULMONARY VEIN ISOLATION. POL ARCH INTERN MED. 2024 FEB 6:16677. DOI: 10.20452/PAMW.16677. EPUB AHEAD OF PRINT. PMID: 38324391. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: PULMONARY VEIN ISOLATION (PVI) IS A RECOMMENDED STRATEGY FOR RHYTHM CONTROL IN ATRIAL FIBRILLATION (AF), BUT ITS SUCCESS RATE REMAINS UNSATISFACTORY. CONTINUOUS RESEARCH IS BEING CONDUCTED TO EXPLORE NEW TECHNOLOGIES AND MODIFICATIONS TO EXISTING ABLATION WORKFLOW IN ORDER TO MITIGATE THE RECURRENCE RATE. OBJECTIVES: THIS STUDY AIMS TO DETERMINE INFLUENCE OF DISTANCE BETWEEN ABLATION LINES ON RECURRENCE RATE IN PATIENTS UNDERGOING FIRST PVI AND THUS TO OPTIMIZE THE PROCEDURE OUTCOMES. PATIENTS AND METHODS: THIS IS A RETROSPECTIVE COHORT STUDY CONDUCTED AT TERTIARY CARE CENTER IN POLAND. A TOTAL OF 146 PATIENTS (MEDIAN AGE: 62 YEARS; 34.3% FEMALE) QUALIFIED FOR FIRST PVI FOR EITHER PAROXYSMAL (N=103) OR PERSISTENT (N=43) AF WERE EVALUATED. THE PROCEDURES WERE PERFORMED WITH THE USE OF A VERY-HIGH-POWER, SHORT-DURATION (VHPSD) CATHETER, QDOT MICROTM (BIOSENSE WEBSTER) OR CONVENTIONAL ABLATION-INDEX-GUIDED THERMOCOOL SMARTTOUCH SF (AI-GUIDED) CATHETER. FREEDOM FROM AF RECURRENCE WAS USED AS A PRIMARY ENDPOINT. THE IMPACT OF INTER-ABLATION LINE DISTANCE ON THE OUTCOME OF PVI, ACCOUNTING FOR CONVENTIONAL RISK FACTORS WAS CALCULATED. RESULTS: GREATER DISTANCE BETWEEN OPPOSITE CIRCUMFERENTIAL PVI LINES (DBL) AND ITS RATIO TO TRANSVERSE DIAMETER OF THE LEFT ATRIUM (DLB/TD) WAS ASSOCIATED WITH LOWER RISK OF AF RECURRENCE (HR: 0.966, 95% CI: 0.935-0.998 [PER 1MM]; P = 0.04 AND HR: 0.968, 95% CI: 0.944-0.993 [PER 1%]; P = 0.01, RESPECTIVELY). CONCLUSIONS: CLOSE PVI LINES LOCATIONS MAY CONTRIBUTE TO AF RECURRENCE THUS INCREASING DBL AND KEEPING HIGHER DBL/TD RATIO MAY BE AN ADVANTAGEOUS ABLATION STRATEGY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT MICRO ABLATION CATHETER (FOR HPSD GROUP), THERMOCOOL SMARTTOUCH SURROUND FLOW (SF) CATHETER (AI GUIDED GROUP) CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO SYSTEM, LASSO MAPPING CATHETER, PENTARAY MAPPING CATHETER NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT MICRO ABLATION CATHETER: ATLEAST QTY 1 (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF CATHETER ATLEAST QTY 1 (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182199 UNK_QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening