BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5053237 · Received September 3, 2015

    Report

    Report Number
    9673241-2015-00596
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 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 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). THE DEVICE WAS NOT RETURNED TO BWI.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT SUFFERED URINARY TRACT INFECTION MORE THAN 7 DAY POST-PROCEDURE WHICH WAS TREATED WITH MEDICATION. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED AND POSSIBLY PROCEDURE RELATED.

    Description of Event or Problem · 1

    THIS EVENT IS PART OF (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN AFIB PROCEDURE. THE PATIENT EXPERIENCED RADIATING CHEST PAIN LESS THAN 7 DAYS AFTER A PROCEDURE. THE PATIENT WAS GIVEN NITRO. CHEST X-RAY, EKG, BLOOD TEST, AND ECHO WERE PERFORMED HOWEVER ALL TEST RESULTS SHOWED NEGATIVE EXCEPT FOR ELEVATED TROPONINS WHICH WERE STILL CONSIDERED TO BE WITHIN NORMAL RANGE FOR POST-PROCEDURE. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE. THE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, ATRIAL FIBRILLATION AND CORONARY ARTERY DISEASE. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED AND POSSIBLY PROCEDURE RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584712 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-SI 17245455L

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R