BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2885849 · Received December 26, 2012

    Report

    Report Number
    9673241-2012-00382
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED, IT WAS IDENTIFIED THAT 1 PIECE WAS SCRAPED; HOWEVER DHR SHOWS THIS PIECE WAS IDENTIFIED DURING THE PROCESS PRIOR THE FINAL INSPECTION STAGE AND DOCUMENTATION SHOWS THE SCRAP OF THIS PIECE EXIST. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL # (B)(4). COOL FLOW PUMP, U.S. SHIP KIT: MODEL #: M-5491-02, SERIAL #: (B)(4). C3 EZ STEER CS WITH AUTO ID: MODEL #: D-1263-07-S, LOT #15712864M. PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WILL NOT RETURNED FOR ANALYSIS. LASSO: MODEL #: D-1220-39-S, LOT #: UNKNOWN_D-1220-39-S. PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WILL NOT RETURNED FOR ANALYSIS. DISTRIBUTED - ACUNAV 8F-90: MODEL #: M-5723-09, LOT #: OEM_M-5723-09, OEM/DIST LOT #: UNKNOWN. PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WILL NOT RETURNED FOR ANALYSIS. REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY BWI FIELD SERVICE ENGINEER. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ICE CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED AND WAS SENT TO OBSERVATION. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THIS EVENT OCCURRED DURING THE ABLATION PHASE. THE PHYSICIAN EXPERIENCED DIFFICULTY IN MANIPULATING THE CATHETER. IT IS UNKNOWN IF THERE WERE ANY ABNORMAL SIGNALS. IT IS UNKNOWN HOW MANY ABLATIONS THE PATIENT RECEIVED BEFORE THE EVENT. THE RF GENERATOR WAS SET TO "POWER-CONTROL" MODE BETWEEN 20W AND 35W. THE TEMPERATURE CUT-OFF SETTING WAS UNKNOWN AND THE HIGH FLOW SETTING WAS 15ML/MIN. A LONG SHEATH WAS USED, BUT THE BRAND IS UNKNOWN. THE ACT MAINTAINED DURING THE PROCEDURE WAS AROUND 300.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15659525L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R