BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THMCL SMARTTOUCH,TC,F,C3

    MDR report key: 7677901 · Received July 11, 2018

    Report

    Report Number
    2029046-2018-01781
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    August 17, 2015
    Report Date
    June 15, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009002
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THIS EVENT IS ORIGINALLY REPORTED IN MFR REPORT # 2029046-2018-01678. ADDITIONAL INFORMATION WAS RECEIVED FROM AUTHOR ON JUNE 15, 2018 REGARDING PATIENT #5 AND THEREFORE SUBMITTED SEPARATELY. IT WAS REPORTED THAT ONE (B)(6) FEMALE PATIENT (PATIENT #5, (B)(6) UNDERWENT RADIOFREQUENCY ABLATION FOR SYMPTOMATIC, PAROXYSMAL ATRIAL FIBRILLATION USING SMARTTOUCH THERMOCOOL ABLATION CATHETER (CATALOG D133602) UNDER FLUOROSCOPIC APPROACH (FLUORO GROUP) ON (B)(6) 2015 AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PATIENT WAS FULLY RECOVERED. THE AUTHOR COMMENTED THAT THE EVENT WAS PROCEDURE RELATED AND RESULTED MILD IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF INTRACARDIAC ECHO (ICE)-GUIDED PULMONARY VEIN ISOLATION (PVI) WITHOUT FLUOROSCOPY. FOUR-HUNDRED EIGHTY-ONE (481) PATIENTS WERE ENROLLED IN THIS STUDY. THE STUDY WAS CONDUCTED BETWEEN JANUARY 1, 2014 AND MARCH 31, 2016. AN OPEN-IRRIGATED SMARTTOUCH THERMOCOOL ABLATION CATHETER WAS USED IN THIS STUDY, HOWEVER LOT NUMBER WERE UNKNOWN. DIAGNOSTIC CATHETER LASSO TEST CATHETER 7FR, DEF,15 MM (CATALOG PRODUCT D-1220-38-S, 35O26R AND D-1079-228-S, 35X58Q) WERE ALSO USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520336 THMCL SMARTTOUCH,TC,F,C3 CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC UNK 10846835009002

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R