BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO¿ XP ELECTROPHYSIOLOGY CATHETER

    MDR report key: 4789150 · Received May 21, 2015

    Report

    Report Number
    9673241-2015-00307
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 24, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE DEVICE HISTORY RECORD (DHR) 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 #: ST-1124 COOL FLOW PUMP MODEL #: M-5491-02 SERIAL #: (B)(4). EZ STEER THERMOCOOL SF NAV CATHETER MODEL #: D-1313-05-S LOT #: 17158371L. PENTARAY NAV ECO CATHETER MODEL #: D-1282-10-S LOT #: 17197574L SOUNDSTAR ECO CATHETER MODEL #: M-5723-15 LOT #: E5008440 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, MALE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A HALO CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. DURING THE PROCEDURE A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A PERICARDIOCENTESIS WAS PERFORMED. OVER 600 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN THE OR AND IN STABLE CONDITION. THE PATIENT WAS TRANSPORTED TO ICU IN STABLE CONDITION WITH A PERICARDIAL DRAINAGE BAG. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. A TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED WITH NON-BWI PRODUCTS. A PULMONARY VEIN ISOLATION (PVI) AND LEFT ISTHMUS LINE WAS PERFORMED PRIOR TO THE INJURY. THE INJURY OCCURRED POST ABLATION, DURING ADDITIONAL STUDY/MAPPING. THE ACT WAS MAINTAINED AROUND 300 DURING THE PROCEDURE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THE PERFORATION OCCURRED AFTER THE PLACEMENT OF HALO CATHETER INTO THE LEFT ATRIUM (LA). THEREFORE, IT POSSIBLY OCCURRED WITH THE HALO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331522 HALO¿ XP ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1160-29-S 16008905L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R