BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5731069 · Received June 16, 2016

    Report

    Report Number
    9673241-2016-00383
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 23, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE DISREGARD THE UDI NUMBER THAT PROVIDED IN THE 3500A REPORT. 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.

    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) FOR THE LOT NUMBER 17387577M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND EXTENDED HOSPITALIZATION. DURING ABLATION PHASE, A TAMPONADE (HYDROPERICARDIUM) WAS OBSERVED. PATIENT WAS IN STABLE CONDITION AND IMPROVED. MEDICAL HISTORY INCLUDES PAROXYSMAL ATRIAL FIBRILLATION OVER 30 YEARS AND GASTRITIS. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK NEEDLE (407206). BIDIRECTIONAL GUIDING SHEATH USED WAS D140011, LOT # W3252392 (NO MAKE OR MODEL NAME REPORTED). GENERATOR PARAMETERS AT THE TIME OF INJURY: POWER CONTROL MODE AT 30 WATTS WITH CUT-OFF AT 30, TEMPERATURE AT 47 DEGREES CELSIUS WITH CUT-OFF AT 48, IMPEDANCE AT 162 OHMS. OVERALL ABLATION TIME AT THE SITE OF INJURY WAS 36.72 SECONDS. LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WAS 747 MILLISECONDS. IRRIGATED CATHETER FLOW WAS SET AT 17 ML/MIN. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. PATIENT RECEIVED ANTICOAGULATION DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED BETWEEN 250-300 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385073 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-04IL-S 17387577M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R