BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF

    MDR report key: 11431346 · Received March 8, 2021

    Report

    Report Number
    2029046-2021-00308
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    December 22, 2020
    Report Date
    February 12, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/13/2021, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. THE PATIENT IS A 53-YEAR-OLD MALE PATIENT (80 KG). THIS ADVERSE EVENT WAS DISCOVERED POST-USE OF BIOSENSE WEBSTER PRODUCTS. THE PATIENT WAS REPORTED AS FULLY RECOVERED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 6/22/2021, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020: DURING A POST-MARKET CLINICAL STUDY, IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION USING AN UNKNOWN THERMOCOOL® SMART TOUCH® SF. ON (B)(6) 2020: RECURRENCE OF ATRIAL FIBRILLATION. ON (B)(6) 2021: THE PATIENT RECOVERED FROM RECURRENCE OF ATRIAL FIBRILLATION. PER THE STUDY INVESTIGATOR, THE FOLLOWING EVENT EVALUATION WAS REPORTED: SERIOUSNESS: SERIOUS. RELATIONSHIP WITH THE DEVICE: UNLIKELY RELATED. RELATIONSHIP WITH THE PROCEDURE: UNLIKELY RELATED. BASED ON THE RESPONSES OF THE INVESTIGATOR THIS WILL CONSERVATIVELY BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331940 THERMOCOOL SMART TOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other