BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 19581777 · Received June 21, 2024

    Report

    Report Number
    2029046-2024-02043
    Event Type
    Injury
    Date Received
    June 21, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: BADERTSCHER P, SERBAN T, ISENEGGER C, KRISAI P, VOELLMIN G, OSSWALD S, KNECHT S, STICHERLING C, KÜHNE M. ROLE OF 3D ELECTRO-ANATOMICAL MAPPING ON PROCEDURAL CHARACTERISTICS AND OUTCOMES IN PULSED-FIELD ABLATION FOR ATRIAL FIBRILLATION. EUROPACE. 2024 MAR 30;26(4):EUAE075. DOI: 10.1093/EUROPACE/EUAE075. PMID: 38525649; PMCID: PMC10984560. 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 CITE HAS BEEN REVIEWED: BADERTSCHER P, SERBAN T, ISENEGGER C, KRISAI P, VOELLMIN G, OSSWALD S, KNECHT S, STICHERLING C, KÜHNE M. ROLE OF 3D ELECTRO-ANATOMICAL MAPPING ON PROCEDURAL CHARACTERISTICS AND OUTCOMES IN PULSED-FIELD ABLATION FOR ATRIAL FIBRILLATION. EUROPACE. 2024 MAR 30;26(4):EUAE075. DOI: 10.1093/EUROPACE/EUAE075. PMID: 38525649; PMCID: PMC10984560. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVE WAS TO COMPARE THE PROCEDURAL CHARACTERISTICS AND OUTCOMES OF PATIENTS WITH AF UNDERGOING PFA FOR PVI WITH MAPPING (N=127) AND WITH NO MAPPING GROUP (N=70). THE MEDIAN FOLLOW-UP WAS 267 (164¿419) DAYS WITH A RECURRENCE-FREE SURVIVAL AFTER 1 YEAR, WHERE THE METHOD OF ABLATION WAS MAPPING AND NON-MAPPING. RESULTS OF THE MAPPING GROUPS WAS THE FOLLOWING: TOTAL PRODECURE DURATION, MIN = 55 (45¿67), LA DWELL TIME, MIN = 38 (30¿49), RECURRENCE = 18 (14%), REDO-PROCEDURES = 9 (7%), AND RECONNECTED PVS = 6/9 (67%). AND, FOR THE NON-MAPPING GROUP: TOTAL PRODECURE DURATION, MIN = 28 (23¿35), LA DWELL TIME, MIN = 15 (11¿21), RECURRENCE = 12 (17%), REDO-PROCEDURES = 6 (9%), AND RECONNECTED PVS = 4/6 (67%). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN OCTARAY CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: N/A CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: FARAWAVE PFA CATHETER (BOSTON SCIENTIFIC, MARLBOROUGH, MA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED OCTARAY CATHETER WHERE THERE WERE TWO COMPLICATIONS IN THE MAPPING GROUP: QTY 1: STROKE (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT) QTY 1: CORONARY ARTERY AIR EMBOLISM (AIR EMBOLISM) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197671 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening