BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER PENTARAY NAV

    MDR report key: 9601537 · Received January 16, 2020

    Report

    Report Number
    MW5092335
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 19, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING EP CRYO-ABLATION CASE, 3D MAP OF BIOSENSE WEBSTER PENTARAY CATHETER WAS NO LONGER VISIBLE AND USABLE. PHYSICIAN TRIED TO REPLACE PENTARAY CATH TO REBUILD 3D MAP BUT TO NO AVAIL. CASE HAD TO BE ABANDONED WITHOUT SUCCESSFUL INTERVENTION. PHYSICIAN REPORTED HE HAS ENCOUNTERED SUCH INTERMITTENT ISSUES IN THE PAST WITH THE PENTARAY CATHETER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57560 BIOSENSE WEBSTER PENTARAY NAV CATHETER, INTRACARDIAL MAPPING HIGH DENSITY ARRAY MTD BIOSENSE WEBSTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other