BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 12600449 · Received October 8, 2021

    Report

    Report Number
    2029046-2021-01710
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    July 28, 2021
    Report Date
    October 8, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). KITAMURA T, FUKAMIZU S, ARAI T, KAWAJIRI K, TANABE S, TOKIOKA S, INAGAKI D, HOJO R. LONG-TERM OUTCOME OF VENTRICULAR TACHYCARDIA ABLATION IN PATIENTS WHO DID NOT UNDERGO PROGRAMMED ELECTRICAL STIMULATION AFTER ABLATION. J INTERV CARD ELECTROPHYSIOL. 2021 JUL 28. DOI: 10.1007/S10840-021-01037-4. EPUB AHEAD OF PRINT. PMID: 34319492. 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KITAMURA T, FUKAMIZU S, ARAI T, KAWAJIRI K, TANABE S, TOKIOKA S, INAGAKI D, HOJO R. LONG-TERM OUTCOME OF VENTRICULAR TACHYCARDIA ABLATION IN PATIENTS WHO DID NOT UNDERGO PROGRAMMED ELECTRICAL STIMULATION AFTER ABLATION. J INTERV CARD ELECTROPHYSIOL. 2021 JUL 28. DOI: 10.1007/S10840-021-01037-4. EPUB AHEAD OF PRINT. PMID: 34319492. OBJECTIVE: VENTRICULAR ARRHYTHMIA INDUCIBILITY IS ONE OF THE IDEAL ENDPOINTS OF VENTRICULAR TACHYCARDIA (VT) ABLATION. HOWEVER, IT MAY BE CHALLENGING TO IMPLEMENT PROGRAMMED ELECTRICAL STIMULATION (PES) AT THE END OF THE PROCEDURE UNDER SEVERAL CIRCUMSTANCES. THE LONG-TERM OUTCOME OF PATIENTS WHO DID NOT UNDERGO PES AFTER VT ABLATION REMAINS LARGELY UNKNOWN. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE DETAILS AND LONG-TERM OUTCOME OF VT ABLATION IN PATIENTS WHO DID NOT UNDERGO PES AT THE END OF THE ABLATION PROCEDURE. METHODS/STUDY DATA: A TOTAL OF 183 ABLATION PROCEDURES IN PATIENTS WITH SHD WHO UNDERWENT CATHETER ABLATION FOR VT BY USING AN IRRIGATED ABLATION CATHETER BETWEEN NOVEMBER 2009 AND DECEMBER 2018 WERE RETROSPECTIVELY SEARCHED. AMONG THE TOTAL OF 183 ABLATION PROCEDURES, WE ENROLLED A TOTAL OF 58 PROCEDURES (31.7%: 58/183), WHERE PES AFTER VT ABLATION WAS NOT PERFORMED. AMONG THE PATIENTS STUDIED, THE MEAN AGE WAS 67 ± 10 YEARS, WITH A MEAN LEFT VENTRICULAR EJECTION FRACTION OF 35 ± 11%. IN ALL PROCEDURES, A 3D MAPPING SYSTEM AND AN IRRIGATED ABLATION CATHETER WERE UTILIZED DURING VT ABLATION. A FORCE-SENSING ABLATION CATHETER, A MULTIPOLAR MAPPING CATHETER, AND AN INTRACARDIAC ECHOCARDIOGRAPHY INCORPORATED WITH THE 3D MAPPING SYSTEM WERE USED IN 44.8%, 69.0%, AND 64.0% OF THE PROCEDURES, RESPECTIVELY. FOLLOWING THIS, PROCEDURE TIME OF > 6 H (AVERAGE 392 ± 59 MIN), COMPLICATIONS (2 CARDIAC TAMPONADE, 2 TRANSIENT ATRIOVENTRICULAR BLOCK, 1 CARDIAC ARREST, 1 AIR EMBOLI IN RIGHT CORONARY ARTERY) WERE OBSERVED. THE AUTHORS DO NOT SPECIFY THE TREATMENTS FOR THESE ADVERSE EVENTS. OF NOTE: THE AUTHORS USED ABLATION CATHETERS FROM 2 DIFFERENT MANUFACTURERS BUT DID NOT PROVIDE INFORMATION TO ASSOCIATE THE FOLLOWING ADVERSE EVENTS WITH SPECIFIC DEVICE MANUFACTURERS. THE ACTUAL NUMBER OF BWI DEVICES ASSOCIATED WITH THESE EVENTS IS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: FORCE-SENSING ABLATION CATHETERS: THERMOCOOL, THERMOCOOL SF, OR THERMOCOOL STSF OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO SYSTEM (BIOSENSE WEBSTER). NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ENSITE MAPPING, (ABBOTT). COOLPATH OR TACTICATH ABLATION CATHETERS (ABBOTT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: 1 CARDIAC ARREST- TREATMENT UNSPECIFIED. 2 CARDIAC TAMPONADE- TREATMENT UNSPECIFIED. 2 TRANSIENT AV BLOCK- TREATMENT UNSPECIFIED. 1 AIR EMBOLI- TREATMENT UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496990 UNK_THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening