BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 14710408 · Received June 16, 2022

    Report

    Report Number
    2029046-2022-01331
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    September 23, 2021
    Report Date
    June 15, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: GRECO CA, ALBANESE M, PISANÒ EC, GARZYA M, DONATEO M, NICOLARDI S, SCOTTO DI QUACQUARO A, MANGIA F, DE RAZZA L, CASALI G, ZACCARIA S. LEFT ATRIAL INTRAMURAL HEMATOMA: THE ROLE OF ECHOCARDIOGRAPHY. ECHOCARDIOGRAPHY. 2021 OCT;38(10):1821-1827. DOI: 10.1111/ECHO.15198. EPUB 2021 SEP 23. PMID: 34555196. 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF #:(B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GRECO CA, ALBANESE M, PISANÒ EC, GARZYA M, DONATEO M, NICOLARDI S, SCOTTO DI QUACQUARO A, MANGIA F, DE RAZZA L, CASALI G, ZACCARIA S. LEFT ATRIAL INTRAMURAL HEMATOMA: THE ROLE OF ECHOCARDIOGRAPHY. ECHOCARDIOGRAPHY. 2021 OCT;38(10):1821-1827. DOI: 10.1111/ECHO.15198. EPUB 2021 SEP 23. PMID: 34555196. OBJECTIVE/METHODS/STUDY DATA: REPORT OF A CASE OF 47 YEAR OLD MAN THAT EXPERIENCED LEFT ATRIAL INTRAMURAL HEMATOMA THAT FOLLOWED A CATHETER ABLATION PROCEDURE AND WAS COMPLICATED BY CARDIAC AND CEREBRAL ISCHEMIA AND REQUIRED CARDIAC SURGICAL MANAGEMENT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3.5 MM IRRIGATION TIB ABLATION CATHETER NAVISTAR THERMOCOOL. CONCOMITANT OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3, CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SL1 SHEATH (ST. JUDE MEDICAL). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: DYSARTHRIA AND RIGHT ARM HYPOSTHENIA RELATED TO ATRIAL HEMATOMA TREATED BY SURGICAL INTERVENTION (NEUROLOGIC DEFICITS RESOLVED WITHIN 10 DAYS AFTER INTERVENTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208725 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention SL1 SHEATH (ST. JUDE MEDICAL)| UNK_CARTO 3