BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3230196 · Received July 16, 2013

    Report

    Report Number
    9673241-2013-00230
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THAT WHEN THIS CATHETER WAS PLUGGED IN THERE WAS NOISE ON THE BODY SURFACE AND INTRACARDIAL ECGS ON BOTH THE CARTO 3 AND THE EP RECORDING SYSTEMS. THE CABLES WERE EXCHANGED BUT DID NOT RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED AFTER THE CATHETER WAS EXCHANGED. ADDITIONAL INFORMATION RECEIVED STATED THE PHYSICIAN WAS NOT ABLE TO INTERPRET ANY SIGNALS DUE TO THE PRESENCE OF NOISE. THE CASE WAS COMPLETED WITHOUT ANY PATIENT¿S CONSEQUENCES. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS ELECTRICALLY TESTED AND IT PASSED SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THAT WHEN THIS CATHETER WAS PLUGGED IN THERE WAS NOISE ON THE BODY SURFACE AND INTRACARDIAL ECGS ON BOTH THE CARTO 3 AND THE EP RECORDING SYSTEMS. THE CABLES WERE EXCHANGED BUT DID NOT RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED AFTER THE CATHETER WAS EXCHANGED. ADDITIONAL INFORMATION RECEIVED STATED THE PHYSICIAN WAS NOT ABLE TO INTERPRET ANY SIGNALS DUE TO THE PRESENCE OF NOISE. THE CASE WAS COMPLETED WITHOUT ANY PATIENT¿S CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328813 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 15853350L

    Patients

    Seq Age Sex Outcome Treatment
    1