BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2029046-2015-00069

    MDR report key: 4649203 · Received April 1, 2015

    Report

    Report Number
    2029046-2015-00069
    Event Type
    Injury
    Date Received
    April 1, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 6, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BWI PRODUCTS IN USE FOR THE PROCEDURE WERE: CARTO 3 SYSTEM: SERIAL# (B)(4); STOCKERT GENERATOR: SERIAL# (B)(4); COOL FLOW PUMP: SERIAL# (B)(4); SMART TOUCH CATHETER: CAT# D132705 LOT# UNKNOWN. 5FRENCH QUADRAPOLAR CATHETER: CAT# AND LOT# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIAL WINDOW WAS PERFORMED AND THEN THE PATIENT WENT TO SURGERY FOR SURGICAL REPAIR. THE PATIENT REMAINS UNSTABLE AND IS REPORTED TO HAVE NO BRAIN ACTIVITY. THE PHYSICIAN¿S OPINION IS THE QUADROPOLAR CATHETER CAUSED THE ADVERSE EVENT. HOWEVER, THE PHYSICIAN DID NOT REPORT A MALFUNCTION OR DIFFICULTY MANIPULATING THE QUAD CATHETER. THE PATIENT DIAGNOSIS RELATED TO THIS EVENT WAS LEFT VENTRICLE PREMATURE VENTRICULAR CONTRACTION (LV PVCS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214937 DRF BIOSENSE WEBSTER, INC (IRWINDALE) WEBSTER QUADROPOLAR - FIXED UNK_WBSTRQDRPLR-FXD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R