BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    MDR report key: 3180799 · Received June 20, 2013

    Report

    Report Number
    9673241-2013-00205
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K892265
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER'S REF. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/(WPW) PROCEDURE, THIS WEBSTER 4 POLE W/AUTO ID CATHETER CAUSED GLOBAL NOISE ON THE CARTO 3 SYSTEM AS WELL AS THE RECORDING SYSTEM. CHANGING THE CATHETER CABLE DID NOT RESOLVE THE ISSUE. CHANGING THIS CATHETER RESOLVED THE ISSUE. THE PROCEDURE WAS CONTINUED WITH NO PATIENT INJURY REPORTED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE PHYSICIAN WAS NOT ABLE TO INTERPRET THE SIGNALS BECAUSE OF THE PRESENCE OF THE NOISE. THE NOISE WAS ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 SYSTEM AND THE EP RECORDING SYSTEM AT THE SAME TIME. THE ISSUE OCCURRED WHEN THEY WERE CONNECTING THE CATHETER. THE SEVERITY OF THE NOISE ON ALL THE CHANNELS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM AT THE SAME TIME IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279586 WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1079-259-S 14008145

    Patients

    Seq Age Sex Outcome Treatment
    1