BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2856799 · Received December 4, 2012

    Report

    Report Number
    9673241-2012-00349
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 12, 2012
    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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT BWI PRODUCTS USED DURING THE PROCEDURE: COOLFLOW PUMP: MFG#: M-5491-01, SERIAL #.: (B)(4). THERMOCOOL SF NAV CATHETER (DEVICE WAS DISCARDED BY THE CUSTOMER/ NOT RETURNED FOR INVESTIGATION): MODEL #: D-1318-03-S, LOT #.: 15374345L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SIDE ATRIAL FIBRILLATION (AFIB) THERE WERE SOME PROBLEMS WITH BUBBLE SENSORS ON THE COOL FLOW PUMP. SOME TROUBLE SHOOTING WAS DONE TO OBTAIN FLOW DURING ABLATION WITHOUT SUCCESS. THE USERS SWITCHED TO USING AN INFUSION PUMP, WHERE THE CUSTOMER NEEDED TO TURN OFF THE INFUSION PUMP PERIODICALLY TO BE ABLE TO SEE ELECTROGRAMS ON THE DISTAL ABLATION CATHETER DUE TO THE COMING FROM THE INFUSION PUMP. THE BUBBLE SENSOR ISSUES ON THE COOL FLOW PUMP WAS NOT INDICATIVE OF A REPORTABLE EVENT. IT WAS STATED THAT SMALL/ MINOR CHAR FORMED ON THE CATHETER TIP DUE TO CHANGE OVER TO THE INFUSION PUMP EVEN THOUGH THE POWER DID NOT EXCEED 30 WATTS. THE APPROXIMATE SIZE/ DESCRIPTION OF THE CHAR WAS NOT PROVIDED. APPROXIMATELY 10 ABLATIONS HAD BEEN PERFORMED; DURATION OF ABLATIONS AT THE SAME SITE WAS 1-2 MINUTES. THE FLOW RATE WAS SET TO 15 ML/MIN; GENERATOR WAS SET ON POWER MODE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1318-03-S 15374345L

    Patients

    Seq Age Sex Outcome Treatment
    1