BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 14912471 · Received July 5, 2022

    Report

    Report Number
    2029046-2022-01505
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    May 1, 2021
    Report Date
    July 4, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    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: BAI XUEYANG , BAI ZHONGLE, LIU GANGQIONG, WANG JIN, HONG JIN, LI LING, DONG JIANZENG . CLINICAL APPLICATION OF ZERO-RAY ATRIAL FIBRILLATION RADIOFREQUENCY ABLATION GUIDED BY SIMPLE INTRACARDIAC ULTRASOUND. CHINESE JOURNAL OF EVIDENCE-BASED CARDIOVASCULAR MEDICINE, MAY 2021, VOL. 13, NO. 5 CHIN J EVID BASED CARDIOVASC MED, MAY, 2021, VOL. 13, NO.5 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. ] 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: BAI XUEYANG , BAI ZHONGLE, LIU GANGQIONG, WANG JIN, HONG JIN, LI LING, DONG JIANZENG . CLINICAL APPLICATION OF ZERO-RAY ATRIAL FIBRILLATION RADIOFREQUENCY ABLATION GUIDED BY SIMPLE INTRACARDIAC ULTRASOUND. CHINESE JOURNAL OF EVIDENCE-BASED CARDIOVASCULAR MEDICINE, MAY 2021, VOL. 13, NO. 5 CHIN J EVID BASED CARDIOVASC MED, MAY, 2021, VOL. 13, NO.5. OBJECTIVE/METHODS/STUDY DATA: -OBJECTIVE TO DISCUSS THE EFFECTIVENESS AND SAFETY OF ZERO-X RAY RADIOFREQUENCY CATHETER ABLATION (RFCA) GUIDED BY A SIMPLE METHOD OF INTRACARDIAC ECHOCARDIOGRAPHY FOR ATRIAL FIBRILLATION (AF). -METHODS AF PATIENTS (N = 120) RECEIVED PLANED RFCA CHOSEN FROM THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY FROM APR. 2020 TO OCT. 2020. ALL PATIENTS WERE DIVIDED INTO CONTROL GROUP RFCA WITH ROUTINE METHOD, AND TEST GROUP UNDERGONE ZERO-X RAY RFCA WITH SIMPLE METHOD OF INTRACARDIAC ECHOCARDIOGRAPHY (EACH N = 60). THE PLACEMENT TIME OF CORONARY SINUS ELECTRODE, TIME OF ATRIAL SEPTAL PUNCTURE, TIME OF LEFT ATRIAL MODELING, THE TOTAL TIME OF PRECONDITIONING, TIME OF X-RAY EXPOSURE AND INCIDENCE OF COMPLICATIONS WERE COMPARED BETWEEN 2 GROUPS. RESULTS THE TIME OF ATRIAL SEPTAL PUNCTURE WAS LONGER A LITTLE (P < 0.001), AND TIME OF LEFT ATRIAL MODELING WAS SHORTER (P < 0.001) IN THE TEST GROUP THAN THOSE IN THE CONTROL GROUP. THE DIFFERENCE IN THE TOTAL TIME OF PRECONDITIONING HAD NO STATISTICAL SIGNIFICANCE BETWEEN 2 GROUPS (P > 0.05). THE TIME OF X-RAY EXPOSURE WAS 0 IN TEST GROUP. CONCLUSION ZERO-X RAY EXPOSURE CAN BE REALIZED IN RFCA GUIDED BY A SIMPLE METHOD OF INTRACARDIAC ECHOCARDIOGRAPHY FOR AF, WHICH IS SAFE AND EFFECTIVE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMART TOUCH NAV, JOHNSON & JOHNSON, USA. OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3 ELECTROANATOMIC MAPPING SYSTEM (V6, JOHNSON & JOHNSON, USA) . SOUNDSTAR, JOHNSON & JOHNSON, USA -DECA NAV, JOHNSON & JOHNSON, USA). PENTARAY NAV, JOHNSON & JOHNSON, USA). NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: TWO ADVERSE EVENTS WERE REPORTED IN THIS LITERATURE SOURCE: DURING ABLATION, THERE WAS ONE CASE OF CARDIAC TAMPONADE WITH PERICARDIOCENTESIS DRAINAGE IN THE CONTROL GROUP. THERE WAS 1 CASE OF SMALL AMOUNT OF PERICARDIAL EFFUSION IN THE TEST GROUP, WITHOUT SPECIAL TREATMENT. THERE WAS NO MENTION OF FURTHER INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449840 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO3 ELECTROANATOMIC MAPPING SYSTEM V6| PENTARAY NAV| SOUNDSTAR