BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2962120 · Received February 14, 2013

    Report

    Report Number
    9673241-2013-00035
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. NO DEFICIENCIES NOTED. 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.(B)(4).

    Additional Manufacturer Narrative · 1

    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). THERMOCOOL SF NAV CATHETER: MODEL #: D-1318-04-S, LOT # 15562083L. DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. SOUNDSTAR 10F-90, GE: MODEL #: M-5723-12, LOT #: OEM_M-5723-12. DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. 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 DURING A LEFT ISCHEMIC VENTRICULAR TACHYCARDIA (L-ISVT) PROCEDURE, THE EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER BECAME ENTRAPPED IN THE PAPILLARY MUSCLE. THE PATIENT IS BEING TRANSFERRED TO ANOTHER FACILITY TO AN EXTRACTION SPECIALIST. THE PATIENT IS CURRENTLY IN STABLE CONDITION. ADDITIONAL INFORMATION WAS REQUESTED ON THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64815 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-04-S 15707338L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R