BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15291109 · Received August 25, 2022

    Report

    Report Number
    2029046-2022-01975
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 24, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SCHLEBERGER R, SCHWARZL JM, MOSER J, NIES M, HÖLLER A, MÜNKLER P, DINSHAW L, JUNGEN C, LEMOINE MD, MAURY P, SACHER F, MARTIN CA, WONG T, ESTNER HL, JAÏS P, WILLEMS S, EICKHOLT C, MEYER C. THE IMPACT OF ULTRA-HIGH-DENSITY MAPPING ON LONG-TERM OUTCOME AFTER CATHETER ABLATION OF VENTRICULAR TACHYCARDIA. SCI REP. 2022 JUN 1;12(1):9139. DOI: 10.1038/S41598-022-12918-7. PMID: 35650230; PMCID: PMC9160260. 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. 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 REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SCHLEBERGER R, SCHWARZL JM, MOSER J, NIES M, HÖLLER A, MÜNKLER P, DINSHAW L, JUNGEN C, LEMOINE MD, MAURY P, SACHER F, MARTIN CA, WONG T, ESTNER HL, JAÏS P, WILLEMS S, EICKHOLT C, MEYER C. THE IMPACT OF ULTRA-HIGH-DENSITY MAPPING ON LONG-TERM OUTCOME AFTER CATHETER ABLATION OF VENTRICULAR TACHYCARDIA. SCI REP. 2022 JUN 1;12(1):9139. DOI: 10.1038/S41598-022-12918-7. PMID: 35650230; PMCID: PMC9160260. OBJECTIVE/METHODS/STUDY DATA: A SINGLE CENTER SEQUENTIAL COMPARISON INCLUDED 122 PATIENTS THAT PRESENTED FOR ABLATION OF SCAR-RELATED VT AT A TERTIARY CARE HOSPITAL. TWO GROUPS FOR MAPPING METHODOLOGIES: ULTRA-HIGH DENSITY 3D MAPPING (UHD) AND CONVENTIONAL POINT-BY-POINT 3D-MAPPING. THE CONVENTIONAL GROUP UTILIZED CARTO 3 SYSTEM. AN ENDOCARDIAL VOLTAGE MAP WAS ACQUIRED THROUGH A RETROGRADE AND/OR ANTEGRADE TRANSSEPTAL ACCESS USING A STEERABLE ABLATION CATHETER (THERMOCOOL®, D- OR F-TYPE, 2-5-2 MM SPACING. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL ABLATION CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO SYSTEM NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: UHD GROUP: UHD MAPPING BY RHYTHMIA (BOSTON SCIENTIFIC), CATHETERS ORION (BOSTON SCIENTIFIC) SLO SHEATH 8.5 F (ST. JUDE MEDICAL), AGILIS LARGE CURVE 8.5 F SHEATH (ST. JUDE MEDICAL) AND TERUMO 8 F (LEUVEN). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (FOR THE CONVENTIONAL GROUP POSSIBLY ASSOCIATED WITH THERMOCOOL ABLATION CATHETER): QTY 1 RIGHT BUNDLE BRANCH BLOCK - ARTICLE DOES NOT DISCUSS INTERVENTIONS; QTY 1 PERIPROCEDURAL STROKE - ARTICLE DOES NOT DISCUSS INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432468 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening AGILIS LARGE CURVE 8.5 F SHEATH (ST. JUDE MEDICAL)| CATHETERS ORION (BOSTON SCIENTIFIC)| SLO SHEATH 8.5 F (ST. JUDE MEDICAL)| TERUMO 8 F (LEUVEN)| UHD MAPPING BY RHYTHMIA (BOSTON SCIENTIFIC)| UNK_CARTO 3