BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6545968 · Received May 4, 2017

    Report

    Report Number
    9673241-2017-00355
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    March 31, 2016
    Report Date
    April 26, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 2, 2017 INDICATING THAT PRODUCT CATALOG IS D-1327-01-S, LASSO (MODEL# UNKNOWN LOT# UNKNOWN) AND SOUNDSTAR (MODEL# UNKNOWN SERIAL# UNKNOWN) DIAGNOSTIC CATHETERS WERE ALSO USED IN THE PROCEDURE. FULL UDI # INFORMATION UNAVAILABLE SINCE THE LOT NUMBER IS UNKNOWN. (B)(4).

    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. CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM, LASSO CATHETER, PENTARAY CATHETER, VIGITAG SYSTEM; I-GELTM; (B)(4); BISTM MONITORING SYSTEMS; (B)(4). THE DEVICE IS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 176 CONSECUTIVE PATIENTS WITH SYMPTOMATIC, DRUG-REFRACTORY ATRIAL FIBRILLATION UNDERWENT THEIR FIRST RADIOFREQUENCY CATHETER ABLATION FROM AUGUST 2014 TO MARCH 2016 (107 IN GA GROUP AND 69 IN CS GROUP). AMONG THEM, ONE PATIENT IN CS GROUP SUFFERED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. TITLE: ¿GENERAL ANESTHESIA IMPROVES CONTACT FORCE AND REDUCES GAP FORMATION IN PULMONARY VEIN ISOLATION: A COMPARISON WITH CONSCIOUS SEDATION¿. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE INFLUENCE OF GENERAL ANESTHESIA ON CONTACT-FORCE PARAMETERS, FORCE¿TIME INTEGRAL (FTI), FTI/WALL THICKNESS AND GAP FORMATION DURING IPSILATERAL PULMONARY VEIN ISOLATION WHEN COMPARED TO CONSCIOUS SEDATION. SUSPECT DEVICE IS A SMARTTOUCH THERMOCOOL CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324375 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-01-S UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R