BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3821826 · Received May 20, 2014

    Report

    Report Number
    9673241-2014-00196
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    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) IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION (AFIB) PROCEDURE THE SIGNAL NOISE OCCURRED DURING ABLATION ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE SIGNALS WERE ALL OVER. THE PHYSICIAN WAS NOT ABLE TO INTERPRET ANY SIGNAL BECAUSE OF THE NOISE. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED IN THIS PROCEDURE. 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) 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

    IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PROXIMAL AND DISTAL SIGNALS OF THE THERMOCOOL SF NAVIGATIONAL CATHETER WERE NOISY DURING ABLATION BOTH ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED IN THIS PROCEDURE. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT ON (B)(6) 2014. THE SIGNAL NOISE OCCURRED DURING ABLATION ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS. THE SIGNALS WERE ALL OVER. THE PHYSICIAN WAS NOT ABLE TO INTERPRET ANY SIGNAL BECAUSE OF THE NOISE. THE SEVERITY OF THE NOISE ON ALL THE CHANNELS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(4) 2014 AS THE AWARENESS DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299590 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 16064834L

    Patients

    Seq Age Sex Outcome Treatment
    1