BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 18943568 · Received March 20, 2024

    Report

    Report Number
    2029046-2024-00956
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    December 7, 2023
    Report Date
    March 20, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    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: LUO T, CHEN Y, XIONG X, CHENG G, DENG C, ZHANG J. EFFICACY AND SAFETY OF THE VEIN OF MARSHALL ETHANOL INFUSION WITH RADIOFREQUENCY CATHETER ABLATION FOR THE TREATMENT OF PERSISTENT ATRIAL FIBRILLATION IN ELDERLY PATIENTS. FRONT CARDIOVASC MED. 2023 DEC 7;10:1276317. DOI: 10.3389/FCVM.2023.1276317. PMID: 38130690; PMCID: PMC10733440. 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: LUO T, CHEN Y, XIONG X, CHENG G, DENG C, ZHANG J. EFFICACY AND SAFETY OF THE VEIN OF MARSHALL ETHANOL INFUSION WITH RADIOFREQUENCY CATHETER ABLATION FOR THE TREATMENT OF PERSISTENT ATRIAL FIBRILLATION IN ELDERLY PATIENTS. FRONT CARDIOVASC MED. 2023 DEC 7;10:1276317. DOI: 10.3389/FCVM.2023.1276317. PMID: 38130690; PMCID: PMC10733440. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: INCREASING AGE IS A SIGNIFICANT RISK FACTOR FOR ATRIAL FIBRILLATION (AF) RECURRENCE AFTER CATHETER ABLATION (CA). WE ACCOMPLISHED THIS STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE VEIN OF MARSHALL (VOM) ETHANOL INFUSION (VOM-EI) WITH CA IN ELDERLY PATIENTS WITH PERSISTENT AF (PSAF). METHODS: THIS RETROSPECTIVE OBSERVATIONAL STUDY INCLUDED 360 CONSECUTIVE ADULT PATIENTS WITH PSAF, OF WHICH 141 WERE IN THE ELDER GROUP (AGE =65 YEARS) AND 219 WERE IN THE YOUNGER GROUP (AGE <65 YEARS), WHO UNDERWENT THE VOM-EI AND RADIOFREQUENCY CA (RFCA) BETWEEN MAY 2020 AND APRIL 2022. THE EFFICACY ENDPOINT WAS NO RECURRENCE OF AF WITHIN ONE YEAR AFTER CA. RESULTS: THE VOM-EI WAS SUCCESSFULLY PERFORMED IN 90.8% OF PATIENTS FROM THE ELDER AND 88.6% FROM THE YOUNGER GROUP. ALL PATIENTS ACHIEVED PVI; 97.9% OF PATIENTS FROM THE ELDER AND 98.6% FROM THE YOUNGER GROUP REACHED LA ROOF BLOCK, AND 93.6% OF PATIENTS FROM THE ELDER AND 95.9% FROM THE YOUNGER GROUP ACHIEVED MI BLOCK. THERE WAS NO SIGNIFICANT DIFFERENCE IN 1-YEAR SURVIVAL WITHOUT RECURRENCE OF AF BETWEEN THE TWO GROUPS (83.0% AND 84.5%, RESPECTIVELY). THE INCIDENCE OF COMPLICATIONS WITHIN 30 DAYS AFTER THE PROCEDURE FROM THE TWO GROUPS WAS LOW AND DID NOT DIFFER SIGNIFICANTLY. CONCLUSION: THE VOM-EI COMBINED WITH RFCA PROVED TO BE AN EFFECTIVE AND SAFE STRATEGY FOR TREATING PSAF IN ELDERLY AND YOUNGER PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: PENTARAY MAPPING CATHETER CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ATERIOVENOUS FISTULA IS ASSOCIATED WITH SHEATHS FOR FEMORAL ACCESS AND THE ARTICLE DOES NOT DISCUSS/IDENTIFY SHEATHS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF ABLATION CATHETER: QTY 2 ACUTE (CARDIAC TAMPONADE) (RECOGNIZED PROCEDURAL COMPLICATION). QTY 5 (PERICARDIAL EFFUSION) WITHOUT PERICARDIOCENTESIS (RECOGNIZED PROCEDURAL COMPLICATION). QTY 3 STROKES (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060562 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening UNK_PENTARAY.