BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 6885281 · Received September 21, 2017

    Report

    Report Number
    9673241-2017-01081
    Event Type
    Death
    Date Received
    September 21, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 23, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. CONCOMITANT PRODUCTS: PENTARAY NAVIGATIONAL CATHETER, U.S. CATALOG: D128208. SOUNDSTAR CATHETER, U.S. CATALOG: 10439011. WEBSTER CORONARY SINUS CATHETER, U.S. CATALOG #: BD710DF282CT. NON-BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL BRK 71 CM TRANSSEPTAL NEEDLE (407200). NON-BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SWARTZ SL0 63 CM 8.5 FRENCH INTRODUCER (407451). NON-BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SWARTZ SL1 63 CM 8.5 FRENCH INTRODUCER (406849). SMARTABLATE GENERATOR. CARTO 3 SYSTEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS), CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION AND PHARMACOLOGIC SUPPORT), AND DEATH. POST-PROCEDURE, A PERICARDIAL EFFUSION WAS DETECTED. NO INTERVENTIONS WERE PERFORMED AT THE TIME OF DISCOVERY. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. REPEAT ECHOCARDIOGRAMS REVEALED NO CHANGE IN THE EFFUSION. WHILE IN THE RECOVERY ROOM, SIX HOURS POST-PROCEDURE, THE PATIENT CODED. PERICARDIOCENTESIS WAS PERFORMED. CARDIOPULMONARY RESUSCITATION (CPR) AND EPINEPHRINE WERE ADMINISTERED. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. ADVERSE EVENTS WERE ASSESSED AS LIFE-THREATENING. PATIENT CONDITION WORSENED, AS THE PATIENT COULD NOT BE RESUSCITATED. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE CARDIAC TAMPONADE IS THAT THE LEFT ATRIAL WALL WAS PERFORATED DURING TRANSSEPTAL PUNCTURE. IT WAS NOTED THAT THE TRANSSEPTAL PUNCTURE SITE WAS VERY ANTERIOR AND IT WAS A DIFFICULT STICK. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH IS THAT THE PERICARDIAL EFFUSION GREW WHILE THE PATIENT WAS IN THE RECOVERY ROOM, WHICH LED TO PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST, WHICH RESULTED IN THE PATIENT¿S DEATH. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK 71 CM TRANSSEPTAL NEEDLE. SHEATHS INCLUDED A ST. JUDE MEDICAL SWARTZ SL0 63 CM 8.5 FRENCH INTRODUCER AND A ST. JUDE MEDICAL SWARTZ SL1 63 CM 8.5 FRENCH INTRODUCER. SMARTABLATE GENERATOR WAS SET ON POWER CONTROL MODE WITH SMARTTOUCH SF SETTINGS. THERE IS NO FURTHER INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. POWER WAS NOT TITRATED. OVERALL ABLATION TIME WAS 55 MINUTES. IRRIGATED CATHETER FLOW WAS SET AT 2 ML/MIN WHILE MAPPING AND 8 ML/MIN WHILE ABLATING AT 25-30 WATTS. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 300-350 SECONDS AND GREATER THAN 350 SECONDS. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE OR CATHETER PROXIMITY. THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663489 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| L| R