BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6662609 · Received June 22, 2017

    Report

    Report Number
    9673241-2017-00508
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 31, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIALLY, IT WAS REPORTED, ¿A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ARTERIOVENOUS FISTULA REQUIRING A SURGICAL STOCKING." ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 PROVIDING ADDITIONAL INFORMATION ON THE PATIENT AND PROCEDURE. IT WAS REPORTED THAT A 60-YEAR-OLD FEMALE PATIENT UNDERWENT AN PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ARTERIOVENOUS FISTULA AND COMPRESSION STOCKINGS WERE APPLIED. THEREFORE, POPULATED FIELDS PATIENT AGE AT THE TIME OF EVENT, AGE UNIT AND A 3. SEX. MANUFACTURER¿S REFERENCE NUMBER: (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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 23, 2017 ON THE EVENT. THE ISSUE RESOLVED WITHOUT SEQUELAE AND THE INTERVENTION NOTED WAS SURGICAL STOCKING. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS DEFINITELY INDEX PROCEDURE-RELATED. ORIGINALLY, THE PRODUCT REPORTED WAS A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER / MODEL #: D-1327-00-S/ LOT #: UNKNOWN_D-1327-00-S. ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 4, 2017 PROVIDING A CORRECTED PRODUCT. THE CORRECT PRODUCT IS THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER / MODEL #: D-1348-05-S /LOT #: UNKNOWN_D-1348-05-S. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER, INC., A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ARTERIOVENOUS FISTULA. ON POST-PROCEDURE DAY 15, THE PATIENT WAS DIAGNOSED WITH AN ARTERIOVENOUS FISTULA. THERE IS NO INFORMATION REGARDING INTERVENTIONS OR EXTENDED HOSPITALIZATION. ISSUE IS ONGOING. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY PROCEDURE-RELATED. SINCE THIS ADVERSE EVENT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442278 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-00-S UNKNOWN_D-1327-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other