BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3771662 · Received April 24, 2014

    Report

    Report Number
    9673241-2014-00155
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. SINCE THE LOT NUMBER IS UNKNOWN, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MFG #:M-4800-01, SERIAL#: (B)(4); STOCKERT 70 SYSTEM, MFG #:M-5463-01, SERIAL#: (B)(4); COOLFLOW PUMP, MFG: M-5491-02, SERIAL#: (B)(4); C3 EZ STEER CS WITH AUTO CATHETER, MFG #: D-1263-06-S, LOT#16049746M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ECHO CONFIRMED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABILIZED. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THE EVENT WAS LIFE THREATENING. WHILE ABLATING THE CAVOTRICUSPID ISHMUS (CTI) LINE IT WAS NOTICED THAT AFTER SEVERAL LESIONS, THE PATIENT¿S BLOOD PRESSURE DROPPED TO 44/40. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABILIZED. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. THE PHYSICIAN NOTICED AN IMPEDANCE RISE. THE PATIENT RECEIVED 8-10 ABLATIONS BEFORE THE EVENT. THE RF GENERATOR WAS SET TO ¿POWER CONTROL¿ MODE AT 30 WATTS. THE TEMPERATURE CUT-OFF SETTING WAS SET TO 41 DEGREES AND THE FLOW SETTING WAS SET TO 30ML/MIN. THE EVENT DID NOT RESULT IN THE IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. THE EVENT DID NOT REQUIRE EXTENDED HOSPITALIZATION STAY. THE PATIENT STABILIZED AND FULLY RECOVERED. THE SRO SHEATH WAS USED. THE PATIENT DID NOT RECEIVE ANY ANTICOAGULATION IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249957 NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S UNKNOWN_D-1197-17-S_JUA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R