BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 6589706 · Received May 24, 2017

    Report

    Report Number
    2029046-2017-00181
    Event Type
    Death
    Date Received
    May 24, 2017
    Date of Event
    May 4, 2017
    Report Date
    May 4, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OBJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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)). SMARTABLATE GENERATOR (MODEL# M-4900-07 SERIAL# (B)(4)). SMARTABLATE PUMP (MODEL# M-4900-08 SERIAL# (B)(4)). PENTARAY NAV ECO CATHETER (MODEL# D-1282-08-S LOT# 17660352L). (B)(4) ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND A SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION), CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION), AND DEATH. DURING THE PROCEDURE, A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. INITIAL PERICARDIOCENTESIS YIELDED 660ML OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS SCHEDULED TO BE TRANSFERRED TO THE CORONARY CARE UNIT FOR OBSERVATION. A LATER REPORT INDICATED THAT 2500ML WAS DRAINED. THORACOTOMY REVEALED A PERFORATION IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND RIGHT VENTRICULAR TRAUMA SECONDARY TO CHEST COMPRESSIONS. INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETER WAS IN THE PATIENT¿S HEART WHILE MONITORING THE TAMPONADE AND REMAINED THERE DURING CHEST COMPRESSIONS. IT WAS NOTED THAT THE ICE (SOUNDSTAR) CATHETER MAY HAVE CONTRIBUTED TO THE INJURIES. MEDICAL HISTORY INCLUDED STEROID MEDICATION THAT IMPAIRED THE INTEGRITY OF THE CARDIAC TISSUE, WHICH MADE IT IMPOSSIBLE FOR THE SURGEON TO REPAIR THE PERFORATION. PATIENT EXPIRED DURING THE SURGICAL INTERVENTION. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION REGARDING THE ADVERSE EVENT OR THE DEATH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367978 SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER SIMILAR DEVICE SNDSTR10, 510K # K070242 OBJ BIOSENSE WEBSTER, INC. (IRWINDALE) M-5723-00 OEM_M-5723-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R