BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID

    MDR report key: 3145487 · Received June 4, 2013

    Report

    Report Number
    2029046-2013-00066
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K090898
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01: SERIAL # 11976. LASSO W/ AUTO ID: MODEL# D-1220-79-S, LOT# UNKNOWN. LASSO W/ AUTO ID: MODEL# D-1220-79-S, LOT# 15817794L. LASSO: MODEL# D-1220-73-S, LOT#15361444L. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, WHEN THE CS CATHETER WAS SEATED THERE WAS THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS NOT ABLE TO INTERPRET THE BOTH BS AND ALL IC RECORDINGS IN SPITE OF THE PRESENCE OF NOISE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED WITHOUT ANY PATIENT CONSEQUENCE. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND IT WAS FOUND WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, WHEN THE CS CATHETER WAS SEATED THERE WAS THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS NOT ABLE TO INTERPRET THE BOTH BS AND ALL IC RECORDINGS IN SPITE OF THE PRESENCE OF NOISE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED WITHOUT ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247307 WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1263-07-S UNKNOWN_D-1263-07-S

    Patients

    Seq Age Sex Outcome Treatment
    1