BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIUS¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 14476592 · Received May 23, 2022

    Report

    Report Number
    2029046-2022-01106
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    February 14, 2019
    Report Date
    May 23, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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: MILJOEN H, ECTOR J, GARWEG C, SAENEN J, HUYBRECHTS W, SARKOZY A, WILLEMS R, HEIDBUCHEL H. DIFFERENTIAL PRESENTATION OF ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA IN ATHLETES AND NON-ATHLETES. EUROPACE. 2019 JUN 1;21(6):944-949. DOI: 10.1093/EUROPACE/EUZ001. PMID: 30768170. 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. PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MILJOEN H, ECTOR J, GARWEG C, SAENEN J, HUYBRECHTS W, SARKOZY A, WILLEMS R, HEIDBUCHEL H. DIFFERENTIAL PRESENTATION OF ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA IN ATHLETES AND NON-ATHLETES. EUROPACE. 2019 JUN 1;21(6):944-949. DOI: 10.1093/EUROPACE/EUZ001. PMID: 30768170. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMED TO EVALUATE THE IMPACT OF ATHLETE HEART REMODELING ON THE PRESENTATION OF ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA. THIS STUDY PERFORMED A RETROSPECTIVE ANALYSIS OF AN ABLATION DATABASE SPANNING PROCEDURES BETWEEN 1995 AND 2017, SELECTING ALL PATIENTS WITH AN ELECTROPHYSIOLOGICALLY CONFIRMED DIAGNOSIS OF ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA. ATHLETES WERE COMPARED WITH HEALTHY NON-ATHLETES. ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA SUBFORMS WERE CLASSIFIED USING TWO DESCRIBED METHODS: THE FIRST METHOD IS ONE PROPOSED BY HEIDBUCHEL AND JACKMAN. THE SECOND METHOD IS ONE PROPOSED BY KATRITSIS AND JOSEPHSON. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 4-MM NON-IRRIGATED CELSIUS CONCOMITANT OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: DAIG 8 FR SL2 SHEATH (BRAND NOT SPECIFIED). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1: TEMPORARY COMPLETE AV BLOCK, RECOVERED COMPLETELY. QTY 1: TEMPORARY COMPLETE AV BLOCK, RESULTING IN 1:1 ANTEROGRADE CONDUCTION WITH A PROLONGED ATRIO-HIS INTERVAL. QTY 1: TEMPORARY 2ND-DEGREE AV-BLOCK, RECOVERED COMPLETELY. QTY 12: STEAM-POP WITHOUT EVIDENCE FOR RESULTING TAMPONADE. QTY 6: THE PROCEDURE WAS STOPPED DUE TO A DEEMED INCREASED RISK OF AV-BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518168 CELSIUS¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other DAIG 8 FR SL2 SHEATH (BRAND NOT SPECIFIED)