BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17951123 · Received October 17, 2023

    Report

    Report Number
    2029046-2023-02340
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: JOHN RM, TEDROW U, TADROS T, RICHARDSON TD, KANAGASUNDRAM A, HOFFMAN RD, KAPP ME, SHAH A, MICHAUD G, STEVENSON W. INTRAMYOCARDIAL HEMATOMA DURING CATHETER ABLATION FOR SCAR-RELATED VENTRICULAR TACHYCARDIA. JACC CLIN ELECTROPHYSIOL. 2023 AUG 11:S2405-500X(23)00516-9. DOI: 10.1016/J.JACEP.2023.07.004. EPUB AHEAD OF PRINT. PMID: 37632506. 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 NOT PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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: JOHN RM, TEDROW U, TADROS T, RICHARDSON TD, KANAGASUNDRAM A, HOFFMAN RD, KAPP ME, SHAH A, MICHAUD G, STEVENSON W. INTRAMYOCARDIAL HEMATOMA DURING CATHETER ABLATION FOR SCAR-RELATED VENTRICULAR TACHYCARDIA. JACC CLIN ELECTROPHYSIOL. 2023 AUG 11:S2405-500X(23)00516-9. DOI: 10.1016/J.JACEP.2023.07.004. EPUB AHEAD OF PRINT. PMID: 37632506. OBJECTIVE/METHODS/STUDY DATA:THE GOAL OF THIS STUDY WAS TO DESCRIBE THE FEATURES AND OUTCOMES OF INTRAMURAL HEMATOMA DURING ABLATION FOR SCAR-RELATED VT. THREE OF THE FOUR CASES INVOLVED BIOSENSE WEBSTER PRODUCTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CASE #1 POSSIBLY ASSOCIATED WITH UNIDENTIFIED BIOSENSE WEBSTER DF CURVE ST/SF (CONTACT FORCE SENSING): QTY 1 BASAL INFEROLATERAL LEFT VENTRICLE HEMATOMA (HEMATOMA) TREATED WITH PERICARDIOCENTESIS, EMERGENCY STERNOTOMY AND PROCOAGULANT COLLAGEN PATCH (SURGICAL INTERVENTION). PATIENT OUTCOME IS DISCHARGED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CASE #2 POSSIBLY ASSOCIATED WITH UNIDENTIFIED BIOSENSE WEBSTER THERMOCOOL DF CURVE ST (CONTACT FORCE SENSING): QTY 1 MID TO DISTAL LATERAL LEFT VENTRICLE HEMATOMA (HEMATOMA) TREATED WITH PERICARDIOCENTESIS, EMERGENCY STERNOTOMY, HEMATOMA UNROOFED, HEMOSTASIS, BIOGLUE AND PERICARDIAL PATCH REPAIR; AORTIC VALVE REPLACEMENT FOR AORTIC STENOSIS ; LEFT VENTRICLE ASSIST DEVICE FOR 1 WEEK AND PROCOAGULANT COLLAGEN PATCH (SURGICAL INTERVENTION). PATIENT OUTCOME IS DISCHARGED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CASE #3 POSSIBLY ASSOCIATED WITH UNIDENTIFIED BIOSENSE WEBSTER THERMOCOOL CELSIUS IRRIGATED RF CATHETER): QTY 1 ANTEROLATERAL LEFT VENTRICLE HEMATOMA (HEMATOMA) TREATED CONSERVATIVELY (MINOR INJURY). PATIENT OUTCOME IS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631295 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other