BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOGA-STAR¿ CARDIOLOGY CATHETER

    MDR report key: 8547642 · Received April 24, 2019

    Report

    Report Number
    2029046-2019-03024
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 1, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: BIOSENSE WEBSTER, INC. PRODUCT - THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER, CATALOG #:D132705, LOT #:UNKNOWN; BIOSENSE WEBSTER, INC. PRODUCT - CARTO® 3 SYSTEM, CATALOG #: FG540000, SERIAL #: (B)(4). MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING PHASE WITH A NOGA-STAR¿ CARDIOLOGY CATHETER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC PERFORATION WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 250CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE ADVERSE EVENT, THE PATIENT WAS PREVIOUSLY SCHEDULED FOR VALVULAR SURGERY DURING SAME STAY. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. NO ABLATION WAS PERFORMED PRIOR TO THE ADVERSE EVENT. THE CATHETER IRRIGATION WAS SET AT 2 ML/MIN. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE CASE. THE FORCE VISUALIZATION FEATURES THAT WERE USED INCLUDED GRAPH, DASHBOARD AND VECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338224 NOGA-STAR¿ CARDIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R