BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10564628 · Received September 21, 2020

    Report

    Report Number
    2029046-2020-01277
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 25, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 10/5/2020. THE PATIENT'S GENDER IS MALE. THE ADVERSE EVENT WAS DISCOVERED POST PROCEDURE. THE PATIENT OUTCOME AFTER THE ADVERSE EVENT WAS THAT THEY FULLY RECOVERED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE 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).

    Description of Event or Problem · 1

    IT WAS REPORTED 08/24/20 DURING CONVERSATION WITH THE PHYSICIAN THAT A PATIENT WHO UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER ON (B)(6) 2020 SUFFERED VAGAL REFLEX [RESPONSE] AFTER THE CASE REQUIRING HOSPITALIZATION. IT WAS REPORTED THAT ABLATION ON THE ESOPHAGUS WAS NOT GOOD, SO THE CLINICAL SPECIALIST ANALYZED THE CASE AND REPORTED THE ABLATION INDEX (AI) VALUES. THERE WERE 7 LESIONS DELIVERED ON THE ESOPHAGUS WITH THE FOLLOWING AI VALUES 458, 291, 233, 231, 209, 209, 206. THE PHYSICIAN¿S COMMENTED THAT IT MAY HAVE BEEN CAUSED BY ABLATION ON THE ESOPHAGUS, BUT THERE IS NO PROBLEM WITH THE PRODUCT. THE PATIENT HAD NAUSEA WITHOUT VOMITING, AND WAS FOLLOWED UP AND DISCHARGED SAFELY ON THE (B)(6). NO MEDICATION WAS ADMINISTERED. BASED ON THE PROVIDED DETAILS IT APPEARS THAT THE PATIENT STAYED IN THE HOSPITAL FOR ABOUT 1 WEEK FOR OBSERVATION. THUS THIS EVENT WILL BE CONSIDERED MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028920 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization