BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 23654407 · Received November 26, 2025

    Report

    Report Number
    2029046-2025-03937
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 26, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KAWAMURA I, KORUTH JS, KUSA S, IWASAWA J, LAM J, ELLSWORTH B, WATANABE K, NIES M, LAMPERT J, MAAN A, MUSIKANTOW DR, TURAGAM MK, MOSS N, WHANG W, MILLER MA, REDDY VY, DUKKIPATI S. OUTCOMES OF SCAR-RELATED VENTRICULAR TACHYCARDIA ABLATION WITH PERCUTANEOUS LEFT VENTRICULAR ASSIST DEVICE SUPPORT. JACC CLIN ELECTROPHYSIOL. 2025 SEP 10:S2405-500X(25)00625-5. DOI: 10.1016/J.JACEP.2025.07.016. EPUB AHEAD OF PRINT. PMID: 40938229. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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: KAWAMURA I, KORUTH JS, KUSA S, IWASAWA J, LAM J, ELLSWORTH B, WATANABE K, NIES M, LAMPERT J, MAAN A, MUSIKANTOW DR, TURAGAM MK, MOSS N, WHANG W, MILLER MA, REDDY VY, DUKKIPATI S. OUTCOMES OF SCAR-RELATED VENTRICULAR TACHYCARDIA ABLATION WITH PERCUTANEOUS LEFT VENTRICULAR ASSIST DEVICE SUPPORT. JACC CLIN ELECTROPHYSIOL. 2025 SEP 10:S2405-500X(25)00625-5. DOI: 10.1016/J.JACEP.2025.07.016. EPUB AHEAD OF PRINT. PMID: 40938229. BACKGROUND: PERCUTANEOUS LEFT VENTRICULAR ASSIST DEVICES (PLVADS) ARE OFTEN USED IN CRITICALLY ILL PATIENTS UNDERGOING SCAR-RELATED VENTRICULAR TACHYCARDIA (VT) ABLATION. HOWEVER, THERE ARE NO RANDOMIZED CONTROLLED TRIALS EVALUATING THEIR BENEFITS. OBJECTIVE: THE GOAL OF THIS STUDY WAS TO COMPARE OUTCOMES BETWEEN PLVAD- AND NON-PLVAD¿SUPPORTED VT ABLATION USING A PROPENSITY SCORE MATCHING ANALYSIS. METHODS: THIS RETROSPECTIVE ANALYSIS COMPRISED 481 SCAR-RELATED VT PATIENTS WHO UNDERWENT CATHETER ABLATION (175 PLVAD AND 306 NON-PLVAD). A 1:1 PROPENSITY SCORE MATCHING WAS CONDUCTED TO BALANCE BASELINE CHARACTERISTICS FOR COMPARISON OF PROCEDURAL AND LONG-TERM OUTCOMES. CONCLUSIONS: THE USE OF PLVADS DURING VT ABLATION IS ASSOCIATED WITH LONGER PROCEDURES AND HIGHER PROCEDURAL COMPLICATIONS WITHOUT ANY BENEFIT IN ACUTE OR LONG-TERM OUTCOMES. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3.5 MM EXTERNALLY IRRIGATED CATHETER (THERMOCOOL NAVISTAR OR SMARTTOUCH; BIOSENSE WEBSTER, INC). OTHER BWI PRODUCTS: (DECANAV OR PENTARAY; BIOSENSE WEBSTER, INC) AND (ACUNAV; BIOSENSE WEBSTER). NON-BWI DEVICES: 8.5-F STEERABLE SHEATH (AGILIS; ST JUDE MEDICAL). 13 CASES OF MAJOR VASCULAR COMPLICATIONS WILL NOT BE CAPTURED AS THE ARTICLE MENTIONED THAT THE SHEATH DEVICE USED WAS FROM THE 8.5-F STEERABLE SHEATH (AGILIS; ST JUDE MEDICAL). BLOOD TRANSFUSION WILL NOT BE INCLUDED AS THIS WILL BE DETERMINED ON A CASE-BY-CASE BASIS BEFORE AND AFTER THE PROCEDURE AND NO RELATION TO THE BWI DEVICES. DEATH WAS NOT CLEARLY MENTIONED IF THIS WAS HAPPENED AFTER THE PROCEDURE RELATED TO THE BWI DEVICES OR NOT. DEATH ARE MOSTLY RELATED TO HEART TRANSPLANT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_THERMOCOOL SF NAV: QTY 33: 33 CASES OF PERIPROCEDURAL DECOMPENSATED HEART FAILURE. NO INTERVENTION MENTIONED. QTY 5: 5 CASES OF CARDIAC TAMPONADE. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812825 UNK_THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening 8.5-F STEERABLE SHEATH (AGILIS, ST JUDE MEDICAL)| DECANAV| PENTARAY