BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6742826 · Received July 25, 2017

    Report

    Report Number
    9673241-2017-00604
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    December 31, 2015
    Report Date
    July 18, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS THAT USED IN THIS STUDY: CARTO 3, CARTOMERGE, LASSO NAV OTHER COMPANY¿S DEVICES THAT WERE USED IN THIS STUDY: MULLINS. MANUFACTURER'S REF. NO: (B)(4). THE DEVICE IS NOT RETURN TO BWI.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED. IT WAS REPORTED ONE (B)(6) FEMALE PATIENT WITH HIGH BMI SUFFERED PHRENIC NERVE PALSY. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE EVENT DID NOT RESULT IN THE IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE AND THE PATIENT WAS FULLY RECOVERED. THE AUTHOR STATED THAT BWI DEVICE CITED IN THE ARTICLE DID NOT LED TO THE REPORTED PATIENT CONSEQUENCES AND THE EVENT WAS PROCEDURE RELATED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 178 PATIENTS (AI-GROUP = 89 AND CF GROUP =89) WITH PAROXYSMAL AF UNDERWENT CATHETER ABLATION FROM JANUARY 2013 AND DECEMBER 2015 AND WERE FOLLOWED-UP FOR 12 MONTHS. AMONG THEM, TWO MAJOR COMPLICATIONS OCCURRED IN THE CF GROUP, WHILE NONE OCCURRED IN THE AI GROUP. ONE PATIENT HAD PHRENIC NERVE PALSY IN THE CF GROUP. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿PROSPECTIVE USE OF ABLATION INDEX TARGETS IMPROVES CLINICAL OUTCOMES FOLLOWING ABLATION FOR ATRIAL FIBRILLATION¿ ABLATION INDEX (AI), A NOVEL ABLATION QUALITY MARKER, INCORPORATES CONTACT FORCE (CF), TIME AND POWER IN A WEIGHTED FORMULA. THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHETHER THE PROSPECTIVE USE OF PREVIOUSLY-PUBLISHED DERIVED AI TARGETS WOULD RESULT IN BETTER OUTCOMES WHEN COMPARED TO CF-GUIDED ABLATION. SUSPECT DEVICE IS A THERMOCOOL SMARTTOUCH, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521678 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-00-S UNKNOWN_D-1327-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other