BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3230201 · Received July 16, 2013

    Report

    Report Number
    9673241-2013-00231
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 27, 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 THERE WAS NOISE ON THE ECGS AND THE DATA STREAM ERROR DISPLAYED ON CARTO 3 WHEN THIS CABLE WAS IN USE. THE ISSUE WAS RESOLVED AFTER THE CABLE AND CATHETER WERE REPLACED. ADDITIONAL INFORMATION PROVIDED STATED THE NOISE OCCURRED THE MINUTE THE CATHETER WAS PLUGGED IN. NOISE OCCURRED ON BOTH THE CARTO AND THE RECORDING SYSTEMS AT THE SAME TIME. THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE AND ALL IC (INTRACARDIAL) RECORDINGS. THE PHYSICIAN WAS NOT ABLE TO INTERPRET NEITHER THE BODY SURFACE NOR ANY IC RECORDINGS DUE TO THE NOISE. THE PROCEDURE 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 THERE WAS NOISE ON THE ECGS AND THE DATA STREAM ERROR DISPLAYED ON CARTO 3 WHEN THIS CABLE WAS IN USE. THE ISSUE WAS RESOLVED AFTER THE CABLE AND CATHETER WERE REPLACED. ADDITIONAL INFORMATION PROVIDED STATED THE NOISE OCCURRED THE MINUTE THE CATHETER WAS PLUGGED IN. NOISE OCCURRED ON BOTH THE CARTO AND THE RECORDING SYSTEMS AT THE SAME TIME. THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE AND ALL IC (INTRACARDIAL) RECORDINGS. THE PHYSICIAN WAS NOT ABLE TO INTERPRET NEITHER THE BODY SURFACE NOR ANY IC RECORDINGS DUE TO THE NOISE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT¿S CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329952 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 15858195L

    Patients

    Seq Age Sex Outcome Treatment
    1