BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 4190112 · Received October 21, 2014

    Report

    Report Number
    9673241-2014-00430
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. FULL UDI # INFORMATION UNAVAILABLE SINCE THE LOT NUMBER IS UNKNOWN. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL#M-4800-01 SERIAL# (B)(4)). STOCKERT 70 SYSTEM (MODEL# M-5463-01 SERIAL# (B)(4)). COOLFLOW PUMP (MODEL# UNKNOWN SERIAL# UNKNOWN). EZ STEER CORONARY SINUS CATHETER (MODEL# D-1263-05-S LOT# UNKNOWN). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/(WPW) PROCEDURE WITH A NAVISTAR THERMOCOOL CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. DURING A PROCEDURE THERE WAS A MILD EFFUSION. IT WAS UNKNOWN IF THE EFFUSION WAS PRE-EXISTING OR IF IT OCCURRED DURING THE PROCEDURE. THE INJURY WAS DISCOVERED DURING THE ABLATION PHASE WHEN THE CATHETER ENTERED THE LEFT SIDE OF THE HEART AND THE PATIENT¿S BLOOD PRESSURE DROPPED. IT WAS CONFIRMED WITH A TRANSTHORACIC PROBE WHICH VISUALIZED THE FLUID IN THE PERICARDIAL SAC. FOLLOWING THE DISCOVERY OF THE EFFUSION, A PERICARDIOCENTESIS WAS PERFORMED AND 275 CC OF FLUID WERE REMOVED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS STABILIZED. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THERE WAS A TRANSSEPTAL PUNCTURE PERFORMED WITH A ST. JUDE BRK NEEDLE. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. HEPARIN WAS USED AND THE ACT WAS MAINTAINED AT 250-300S. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. SETTINGS DURING THE EVENT INCLUDE: POWER CONTROLLED - 30 WATTS / IRRIGATION FLOW SETTING - 17 ML/MIN. THE POWER WAS NOT TITRATED DURING ABLATION. THE OVERALL TIME FOR ABLATION AT THE SITE WAS FIVE SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668367 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 Life Threatening| R