BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEBSTER¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3826593 · Received May 22, 2014

    Report

    Report Number
    2029046-2014-00148
    Event Type
    Death
    Date Received
    May 22, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    K892265
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A) SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. B) CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000, SERIAL # (B)(4). PRODUCT: STOCKERT 70 RF GENERATOR: US CATALOG # S7001, SERIAL # UNKNOWN. PRODUCT: COOLFLOW® IRRIGATION PUMP: US CATALOG # CFP002, SERIAL # UNKNOWN. PRODUCT: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER: US CATALOG # D132704, LOT # 16075936M. (B)(4).

    Description of Event or Problem · 1

    DURING A VENTRICULAR TACHYCARDIA PROCEDURE, IT WAS REPORTED THAT A CARDIAC PERFORATION WAS DISCOVERED DURING MAPPING AFTER PERFORMING ONLY ONE ABLATION. THE HOLE WAS DISCOVERED WHERE THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WENT THROUGH AND NOT WHERE IT WAS ABLATED. WINDOW PROCEDURE WAS PERFORMED AND PERFORATION SUTURED. THE PATIENT WAS STABLE. ON (B)(4), RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT THIS EVENT OCCURRED DURING MAPPING OF A PATIENT WITH INCESSANT VT, WHO HAD AN EXTENSIVE CARDIAC HX, INCLUDING ISCHEMIA AND ICD. THE PHYSICIAN DECISION WAS TO MAP WITH THE SMART TOUCH CATHETER IN LEFT VENTRICLE (LV), SEARCH FOR SCAR AREAS AND USE PACE MAPPING TO DETERMINE THE PROPER AREAS TO DELIVER THERAPY. AFTER MAPPING THE LV AND DEFINING THE SCARED AREAS, THE PACING MAPPING DID NOT SHOW THE MORPHOLOGY WAS COMING FROM THE LV, IT WAS COMING FROM THE RIGHT VENTRICLE (RV) APEX AREA. THE CATHETER WAS REMOVED FROM THE LV AND INSERTED TO THE RV, WHERE THE PHYSICIAN BEGAN PACE MAPPING TO RECREATE THE MORPHOLOGY. THE MATCHING MORPHOLOGY WAS FOUND NEAR THE RV APEX AND THE PHYSICIAN DELIVERED A RADIOFREQUENCY (RF) LESION AT 20 WATTS CLOSE TO THE RV APEX, HOWEVER, MORE FREE WALL. AFTER THE LESION, CONTINUED TO MAP TO FIND MORE AREAS OF INTEREST WHEN THE SMART TOUCH CATHETER VECTOR ARROW TURNED RED THEN GREY AND THE CATHETER APPEARED TO BE OUTSIDE OF THE GEOMETRY ALREADY CREATED. THE PHYSICIAN IMMEDIATELY STARED TO MONITOR THE PATIENT FOR TAMPONADE. IT WAS DETERMINED THE PATIENT NEEDED CARDIAC SURGERY AFTER THE PATIENT WAS NOT ABLE TO MAINTAIN AN ADEQUATE BLOOD PRESSURE AND ECHO CONFIRMED A TAMPONADE. IT WAS DETERMINED THAT THE TAMPONADE WAS A RESULT OF MAPPING AND NOT OF THE RF LESION BECAUSE THE PHYSICIAN WAS ABLE TO VISUALIZE THE AREA WHERE THE RF LESION WAS PERFORMED IN PROXIMITY TO THE PERFORATION. THE PHYSICIAN WAS NOT SURE IF THE EVENT WAS DIRECTLY RELATED TO THE PATIENT¿S DEATH, HOWEVER COULD HAVE BEEN A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304801 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER ELECTRODE, PACEMAKER, TEMPORARY OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1085-205-S UNKNOWN_D-1085-205-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death