BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 5097520 · Received September 23, 2015

    Report

    Report Number
    9673241-2015-00668
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A AFIB PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF ABLATION CATHETER AND SUFFERED LEFT ATRIAL RE-ENTRY TACHYCARDIA WHICH REQUIRED RE-ABLATION PROCEDURE AND HOSPITALIZATION. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE RETURNED DEVICE WAS THEN EVALUATED FOR ELECTRICAL RESISTANCE AND THE THERMOCOUPLE TEST FAILED. FURTHER EXAMINATION REVEALED THAT THE THERMOCOUPLE WIRES WERE DISCONNECTED INSIDE THE DOME. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17235805L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED FOR TEMPERATURE ISSUE.

    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. THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN 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 SMART TOUCH UNIDIRECTIONAL APPROVED UNDER P030031/S053. (B)(4). METHODS: NO TESTING METHODS PERFORMED; RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED; CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP; MANUFACTURER'S REF. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS EVENT IS PART OF (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN AFIB PROCEDURE. DURING PROCEDURE THE TEMPERATURE WAS NOT BEING DISPLAYED AND WOULD NOT ALLOW ABLATION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. MORE THAN 7 DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED LEFT ATRIAL RE-ENTRY TACHYCARDIA. THE PATIENT REQUIRED RE-ABLATION PROCEDURE AND HOSPITALIZATION. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE. THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, ATRIAL FIBRILLATION AND HYPERLIPIDEMIA. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED AND POSSIBLY PROCEDURE RELATED. THIS PATIENT EVENT WAS ORIGINALLY REPORTED UNDER REPORT # 9673241-2015-00598. ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 03, 2015 INDICATING THAT ADDITIONAL SUSPECT DEVICES WERE PRESENT. AS SUCH, THE CURRENT REPORT IS BEING SUBMITTED AND THE AWARENESS DATE FOR THIS SUSPECT DEVICE IS SEPTEMBER 03, 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628010 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-01-SI 17235805L

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R