BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2973788 · Received February 22, 2013

    Report

    Report Number
    9673241-2013-00048
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING AN AFIB - PAROXYSMAL PROCEDURE, IT WAS REPORTED THAT AFTER APPROXIMATELY 2 MINUTES OF ABLATION WITH THIS SF CATHETER A TEMP LIMITER ERROR APPEARED ON THE STOCKERT GENERATOR. THE PHYSICIAN ABLATED IN A DIFFERENT LOCATION IN THE HEART AND THE ERROR IMMEDIATELY RETURNED. THE CATHETER WAS REMOVED FROM THE PATIENT AND CHAR WAS NOTICED ON THE TIP AND THE CATHETER WOULD NOT FLUSH PROPERLY. THE CATHETER DID NOT HAVE FLUSHING ISSUE PRIOR TO USE. IT WAS NOTICED THE COOL FLOW PUMP TUBING'S STOPCOCK WAS PARTIALLY CLOSED. THE SF CATHETER WAS REPLACED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT'S CONSEQUENCE. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. NO CHAR WAS OBSERVED. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING AN AFIB - PAROXYSMAL PROCEDURE, IT WAS REPORTED THAT AFTER APPROXIMATELY 2 MINUTES OF ABLATION WITH THIS SF CATHETER A TEMP LIMITER ERROR APPEARED ON THE STOCKERT GENERATOR. THE PHYSICIAN ABLATED IN A DIFFERENT LOCATION IN THE HEART AND THE ERROR IMMEDIATELY RETURNED. THE CATHETER WAS REMOVED FROM THE PATIENT AND CHAR WAS NOTICED ON THE TIP AND THE CATHETER WOULD NOT FLUSH PROPERLY. THE CATHETER DID NOT HAVE FLUSHING ISSUE PRIOR TO USE. IT WAS NOTICED THE COOL FLOW PUMP TUBING'S STOPCOCK WAS PARTIALLY CLOSED. THE SF CATHETER WAS REPLACED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79103 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-02-S 15681714L

    Patients

    Seq Age Sex Outcome Treatment
    1