BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 20388931 · Received October 7, 2024

    Report

    Report Number
    2029046-2024-03304
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. E1 INITIAL REPORTER ADDRESS LINE 1: (B)(6) HOSPITAL OF (B)(6). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LI J, WANG Z, QIN F, LUO F, CHEN J, LIU Y, TAO H, DONG J. LEFT PULMONARY VEIN TRUNK LENGTH AS A ROBUST PREDICTOR OF LONG-TERM SUCCESS OF ATRIAL FIBRILLATION CATHETER ABLATION. REV CARDIOVASC MED. 2024 AUG 22;25(8):301. DOI: 10.31083/J.RCM2508301. PMID: 39228486; PMCID: PMC11367007. 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: LI J, WANG Z, QIN F, LUO F, CHEN J, LIU Y, TAO H, DONG J. LEFT PULMONARY VEIN TRUNK LENGTH AS A ROBUST PREDICTOR OF LONG-TERM SUCCESS OF ATRIAL FIBRILLATION CATHETER ABLATION. REV CARDIOVASC MED. 2024 AUG 22;25(8):301. DOI: 10.31083/J. RCM2508301. PMID: 39228486; PMCID: PMC11367007. OBJECTIVE/METHODS/STUDY DATA: RADIOFREQUENCY CATHETER ABLATION (RFCA) IS A COMMONLY USED TREATMENT FOR ATRIAL FIBRILLATION (AF), BUT THE LONG-TERM RECURRENCE RATE REMAINS RELATIVELY HIGH. GIVEN THE INCONSISTENT RESULTS REGARDING THE ROLE OF LEFT PULMONARY VEIN (PV) OSTIAL ANATOMY IN POST-ABLATIVE RECURRENCE OF RFCA IN PREVIOUS STUDIES, WE SOUGHT TO INVESTIGATE THE ROLE OF LEFT PV TRUNK LENGTH USING AN ALTERNATIVE METHODOLOGY. METHODS: A TOTAL OF (B)(4) PATIENTS UNDERGOING CATHETER ABLATION WERE INCLUDED. THE LEFT/RIGHT TRUNK LENGTH (LTL/RTL) OF THE PV WAS MEASURED FROM PRE-ABLATIVE COMPUTED TOMOGRAPHY (CT) USING THREE-DIMENSIONAL RECONSTRUCTION TECHNIQUES. WE CONSTRUCTED (B)(4) MULTIVARIABLE COX MODELS, WITH THE INCLUSION OF THE LTL, RTL, AND NO LTL/RTL, AND USED THE DELONG TEST, INTEGRATED DISCRIMINATION INDEX (IDI), AND NET RECLASSIFICATION INDEX (NRI) TO ASSESS MODEL IMPROVEMENT. WE IDENTIFIED OPTIMAL CUT-OFF VALUES FOR LTL WITH THE RECEIVER OPERATING CHARACTERISTIC (ROC) CURVE, AND ESTIMATED OUTCOMES USING THE KAPLAN-MEIER SURVIVAL CURVE. WE ALSO USED SUBGROUP ANALYSIS TO EVALUATE INTERACTIONS. RESULTS: THE RESULTS OF THE DELONG TEST, IDI, AND NRI INDICATED THAT LTL HAD A FAVORABLE IMPACT ON THE PERFORMANCE OF THE MULTIVARIATE MODEL. SUBSEQUENTLY, THE MULTIVARIATE COX REGRESSION ANALYSIS IDENTIFIED LTL AS A SIGNIFICANT RISK FACTOR FOR POST-ABLATIVE RECURRENCE OF AF (ADJUSTED HAZARD RATIO (HR) = (B)(4), P < (B)(4)). ACCORDING TO THE ROC CURVE, THE OPTIMAL CUT-OFF VALUE FOR LTL IS 11.15 MM, AND THE KAPLAN-MEIER ESTIMATOR REVEALED DIFFERENT OUTCOMES (P < (B)(4)). WE CALCULATED P FOR INTERACTION BETWEEN LTL AND OTHER FACTORS, AND NO SIGNIFICANT INTERACTION TERMS WERE OBSERVED. CONCLUSIONS: LTL IS A ROBUST PROGNOSTIC INDICATOR FOR POST-ABLATIVE OUTCOME IN AF PATIENTS RECEIVING RFCA, WITH A LONGER LTL INDICATING A HIGHER RISK OF RECURRENCE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMO-COOL SMARTTOUCH CATHETER. CONCOMITANT BIOSENSE WEBSTER DEVICE THAT WAS ALSO USED IN THIS STUDY: CARTO 3 MAPPING SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMO-COOL SMARTTOUCH CATHETER (QTY (B)(4)) -(QTY (B)(4)) (B)(4) PATIENTS HAD UNSPECIFIED SEVERE POST-ABLATIVE COMPLICATIONS. THE TREATMENT PROVIDED WAS NOT REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539762 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other UNK_CARTO 3.