BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3081309 · Received April 26, 2013

    Report

    Report Number
    9673241-2013-00137
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS INVESTIGATION COULD NOT BE CONDUCTED SINCE THE CATHETER WAS DISPOSED BY THE CUSTOMER. NO DHR WAS PERFORMED BECAUSE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US CATALOG #: FG540000, SERIAL #: (B)(4). STOCKERT 70 SYSTEM US CATALOG #: S7001, SERIAL #: (B)(4). COOL FLOW PUMP US CATALOG #: CFP002, SERIAL #: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT ATRIAL FLUTTER (R-AFL) PROCEDURE, NO ATRIAL OR VENTRICULAR ACTIVITY WAS NOTICED AFTER ABLATING. THE REPORTER STATED THAT THIS CONDITION WAS NOTICED AND CONFIRMED BY THE FLAT LINE DISPLAYED ON THE BS ELECTROCARDIOGRAMS. PACING OF THE HEART TOOK PLACE THROUGH THE CORONARY SINUS AND THE ATRIOVENTRICULAR NODE APPEARED TO BE RECOVERED. HOWEVER, THE REPORTER WAS NOT SURE IF THE SINO-ATRIAL (SA) NODE WAS RECOVERED OR NOT. THE REPORTER BELIEVED THAT A TEMPORARY PACEMAKER AND ATROPINE WERE GIVEN TO THE PATIENT. THE STATUS OF THE PATIENT WAS UNKNOWN AT THE TIME OF THE EVENT, HOWEVER, A FOLLOW UP CALL WAS RECEIVED FROM THE CLINICAL SPECIALIST SAME DAY OF THE EVENT AND IT WAS STATED THAT THE PATIENT WAS RECOVERED. THREE ATTEMPTS WERE PERFORMED TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181099 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1318-00-S UNKNOWN_D-1318-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R