BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4903457 · Received July 9, 2015

    Report

    Report Number
    9673241-2015-00433
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL# (B)(4)) STOCKERT (MODEL# M-5463-01 SERIAL# (B)(4)) COOL FLOW PUMP (MODEL# UNKNOWN SERIAL# (B)(4)) SOUNDSTAR CATHETER (MODEL# M-5723-12 LOT# S1424586) EZ STEER THERMOCOOL SF NAV CATHETER (MODEL# D-1313-05-S LOT# 17072204L) (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT A LEFT SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE WITH AN SMARTTOUCH BIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. DURING THE MAPPING PHASE OF THE PROCEDURE A PERFORATION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERFORATION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND 500CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THIS COMPLAINT WAS REPORTED.ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. IT WAS NOTED THAT THIS PATIENT HAD A MEDICAL HISTORY OF A SMALL VENTRICLE THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THE PATIENT RECEIVED ANTICOAGULATION DURING THE PROCEDURE AND IT WAS MAINTAINED AT 300-350S. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION DUE TO THE EVENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE RELATED. SETTINGS DURING THE EVENT INCLUDE: POWER CONTROL / IRRIGATION FLOW SETTING 2 ML/MIN / 8F PINNACLE SHEATH USED. THERE WAS AN R1 ERROR THAT DISPLAYED ON THE COOLFLOW PUMP; THEREFORE IT WAS SWITCHED OUT FOR ANOTHER PUMP THAT HAD REPEATING BF ERRORS. THESE ERRORS ARE NOT REPORTABLE AS THEY ARE HIGHLY DETECTABLE AND THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446923 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R