BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 11829476 · Received May 14, 2021

    Report

    Report Number
    2029046-2021-00760
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    May 29, 2018
    Report Date
    April 29, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2021-00761, 2029046-2021-00762 ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 2 PATIENTS UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED TAMPONADE. INTERVENTION WAS NOT REPORTED. (THERMOCOOL SF). MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THERMOCOOL SF. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3, CARTO XP, CARTO RMT. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. PUBLICATION DETAILS: TITLE: CATHETER ABLATION OR MEDICAL THERAPY TO DELAY PROGRESSION OF ATRIAL FIBRILLATION: THE RANDOMIZED CONTROLLED ATRIAL FIBRILLATION PROGRESSION TRIAL (ATTEST). OBJECTIVE: DELAY OF PROGRESSION FROM PAROXYSMAL TO PERSISTENT ATRIAL FIBRILLATION (AF) IS AN IMPORTANT MEASURE OF LONG-TERM SUCCESS OF AF TREATMENT. HOWEVER, PUBLISHED DATA ON THE IMPACT OF CATHETER ABLATION ON AF PROGRESSION ARE LIMITED. THIS STUDY EVALUATES WHETHER RADIOFREQUENCY (RF) CATHETER ABLATION DELAYS THE PROGRESSION OF AF COMPARED WITH ANTIARRHYTHMIC DRUG (AAD) TREATMENT USING CURRENT AF MANAGEMENT GUIDELINES. METHODS: THIS PROSPECTIVE, RANDOMIZED, CONTROLLED, TWO-ARM, OPEN-LABEL TRIAL WAS CONDUCTED AT 29 HOSPITALS AND MEDICAL CENTRES ACROSS 13 COUNTRIES. PATIENTS WERE RANDOMIZED 1 : 1 TO RF ABLATION OR AAD TREATMENT. THE PRIMARY ENDPOINT WAS THE RATE OF PERSISTENT AF/ATRIAL TACHYCARDIA (AT) AT 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725652 UNK_SMART TOUCH BIDIRECTIONAL SF UNK OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening