BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿

    MDR report key: 3632554 · Received February 18, 2014

    Report

    Report Number
    9673241-2014-00059
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    September 3, 2013
    Report Date
    January 28, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER APPROVED UNDER P030031/S034. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DURING ABLATION FOR THIS PROCEDURE, NOISE WAS REPORTED ON THE SMART TOUCH UNIDIRECTIONAL CATHETER ON BOTH THE CARTO SYSTEM AND THE BARD RECORDING SYSTEM. THE CATHETER CABLES WERE REPLACED WITHOUT THE PROBLEM BEING FIXED. THE ISSUE WAS RESOLVED WHEN THIS CATHETER WAS REPLACED. THERE WAS NO CONSEQUENCE TO THE PATIENT DUE TO THIS ISSUE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND IT WAS FOUND WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING ABLATION FOR THIS PROCEDURE, NOISE WAS REPORTED ON THE SMART TOUCH UNIDIRECTIONAL CATHETER ON BOTH THE CARTO SYSTEM AND THE BARD RECORDING SYSTEM. THE CATHETER CABLES WERE REPLACED WITHOUT THE PROBLEM BEING FIXED. THE ISSUE WAS RESOLVED WHEN THIS CATHETER WAS REPLACED. THERE WAS NO CONSEQUENCE TO THE PATIENT DUE TO THIS ISSUE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT ON (B)(6) 2014. THERE WAS NOISE ON ALL BODY SURFACE (BS) AND INTRACARDIAC (IC) RECORDINGS ON BOTH THE CARTO SYSTEM AND THE BARD RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS UNABLE TO INTERPRET THE SIGNALS WITH THE NOISE. THE PROCEDURE COULD NOT CONTINUE WITH THIS STATE OF NOISE. PER THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014, STATING THE SEVERITY OF THE NOISE ON ALL THE BS AND IC RECORDINGS ON BOTH THE CARTO AND THE BARD RECORDING SYSTEM AT THE SAME TIME IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(6) 2014 AS THE AWARENESS DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102666 THERMOCOOL® SMART TOUCH¿ OAE BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S 15819231MB

    Patients

    Seq Age Sex Outcome Treatment
    1