BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5184048 · Received October 28, 2015

    Report

    Report Number
    9673241-2015-00776
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    August 17, 2015
    Report Date
    October 27, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. 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 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 SMART TOUCH BIDIRECTIONAL 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. (B)(4) THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS EVENT IS PART OF SMART-SF CLINICAL STUDY. IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WITH A MEDICAL HISTORY OF SYMPTOMATIC ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, HYPERTENSION, CONGESTIVE HEART FAILURE UNDERWENT A PULMONARY VEIN ISOLATION PROCEDURE. THE PATIENT HAD CHEST PAIN/DISCOMFORT MORE THAN 7 DAYS POST PROCEDURE. THE PATIENT HAD A ER VISIT AND WAS PRESCRIBED FLEXERIL. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED AND POSSIBLY PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713694 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-SI 17248881L

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R