BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16463010 · Received March 1, 2023

    Report

    Report Number
    2029046-2023-00427
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    November 10, 2022
    Report Date
    March 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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:LI X, LI M, ZHANG Y, ZHANG H, WU W, RAN B, LI X, TANG Q, FU B. SIMPLIFIED STEPWISE ANATOMICAL ABLATION STRATEGY FOR MITRAL ISTHMUS: EFFICACY, EFFICIENCY, SAFETY, AND OUTCOME. EUROPACE. 2022 NOV 10:EUAC204. DOI: 10.1093/EUROPACE/EUAC204. EPUB AHEAD OF PRINT. PMID: 36353823. 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 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 REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:LI X, LI M, ZHANG Y, ZHANG H, WU W, RAN B, LI X, TANG Q, FU B. SIMPLIFIED STEPWISE ANATOMICAL ABLATION STRATEGY FOR MITRAL ISTHMUS: EFFICACY, EFFICIENCY, SAFETY, AND OUTCOME. EUROPACE. 2022 NOV 10:EUAC204. DOI: 10.1093/EUROPACE/EUAC204. EPUB AHEAD OF PRINT. PMID: 36353823. AIMS: BIDIRECTIONAL AND DURABLE BLOCK OF MITRAL ISTHMUS (MI) IS ESSENTIAL FOR CATHETER ABLATION OF PERSISTENT ATRIAL FIBRILLATION (PEAF) AND PERIMITRAL FLUTTER (PMF), BUT IT REMAINS A CHALLENGE. THE AIM OF THIS STUDY WAS TO CREATE A SIMPLE ANATOMICAL ABLATION STRATEGY WITH MINIMAL FLUOROSCOPY THAT WOULD YIELD A HIGH SUCCESS RATE FOR MI BLOCK.METHODS AND RESULTS: PATIENTS WITH PEAF OR PMF WERE INCLUDED. MITRAL ISTHMUS WAS ABLATED IN A STEPWISE STRATEGY. IN STEP 1, ENDOCARDIAL MI LINEAR ABLATION WAS PERFORMED; IN STEP 2, ABLATION WAS TARGETED TO THE POSTEROLATERAL PORTION OF THE LEFT ATRIUM ALONG THE MI LINE; IN STEP 3, EPICARDIAL ABLATION WITHIN THE CORONARY SINUS (CS) WAS PERFORMED ACROSS THE MI LINE TO THE OSTIUM OF THE VEIN OF MARSHALL (VOM) OR PERFORMED WITHIN THE VOM IF AVAILABLE; IN STEP 4, THE CATHETER WAS ROTATED AND ABLATED IN THE CS TO ISOLATE THE CS; AND IN STEP 5, THE EARLY ACTIVATION SITE WITH COMPLEX COMPONENT POTENTIAL ABOVE THE MI LINE DURING DISTAL CS PACING WAS CONSIDERED AS THE ABLATION TARGET. ALL PATIENTS WERE FOLLOWED UP. A TOTAL OF 178 (17 PATIENTS WITH MECHANICAL PROSTHETIC MITRAL VALVE) WERE INCLUDED. ONE HUNDRED AND SIXTY-SIX PATIENTS ACHIEVED A CONFIRMED MI BIDIRECTIONAL CONDUCTION BLOCK (93%). ONE PATIENT HAD CARDIAC TAMPONADE. FOUR PATIENTS SHOWED RE-CONDUCTION ACROSS THE MI LINE DURING A REPEATED ABLATION. IN THE LATEST FOLLOW-UP [12 (7, 16) MONTHS], 161 OF 178 (90%) PATIENTS MAINTAINED THEIR SINUS RHYTHM.CONCLUSION: A SIMPLE STEPWISE ANATOMICAL ABLATION STRATEGY FOR MI SHOWS A HIGH SUCCESS RATE WITH LOW FLUOROSCOPY EXPOSURE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS:THERMOCOOL SMARTTOUCH SF FOR ABLATION CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 FOR MAPPING. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 8.5-FR SL-1 SHEATH (ST. JUDE MEDICAL). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ONE PATIENT HAD CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147786 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L 8.5-FR SL-1 SHEATH (ST. JUDE MEDICAL).| UNK_CARTO 3.