BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6637643 · Received June 13, 2017

    Report

    Report Number
    9673241-2017-00452
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 17, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNSPECIFIED NEEDLE. THERE WAS NO SHEATH INFORMATION. GENERATOR WAS SET ON POWER CONTROL MODE. THERE WAS NO INFORMATION REGARDING GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. THERE WAS NO INFORMATION REGARDING IRRIGATED CATHETER FLOW SETTING OR ANTICOAGULATION DURING THE PROCEDURE. THERE WAS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE, CATHETER PROXIMITY, OR CATHETER ZEROING. THE SOUNDSTAR ECO CATHETER WAS CONNECTED TO BOTH THE CARTO AND THE ULTRASOUND SYSTEM WHEN THE ISSUE OCCURRED. THERE WAS NO INFORMATION REGARDING IF THE MAPPING CATHETER WAS CONNECTED TO THE CARTO PRIOR TO CONNECTING THE SOUNDSTAR ECO CATHETER. CARTOSOUND/ULS WAS SELECTED ON THE CARTO SYSTEM AND THE NAME OF THE ULS WAS SELECTED ON THE CARTO SYSTEM. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17636470L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCT: SOUNDSTAR ECO CATHETER, MODEL #: M-5723-18, LOT #: G9034903; CARTO 3 SYSTEM, MODEL #: UNKNOWN, SERIAL #: UNKNOWN; NON BIOSENSE WEBSTER, INC. - GE VIVID I PORTABLE ULTRASOUND SYSTEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. ERROR 6150 DISPLAYED WHEN SOUNDMERGE WAS GOING TO BE CONDUCTED. IT WAS NOTED THAT THERE WAS NO COMMUNICATION PROBLEM WITH THE ULTRASOUND SYSTEM PRE-PROCEDURE. SOUNDSTAR CATHETER AND CABLE WERE RECONNECTED WITHOUT RESOLUTION. CABLE WAS REPLACED WITHOUT RESOLUTION. SOUNDSTAR ECO CATHETER WAS REPLACED AND THE ISSUE IMPROVED. THE INCIDENCE OF MAGNETIC SENSOR ERROR IS EASY DETECTABLE BY THE USER. THE CATHETER IS INOPERABLE , SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WILL HAVE TO REPLACE THE CATHETER. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THEREFORE THIS ISSUE WAS ASSESSED AS NOT REPORTABLE. UPON INITIATION OF ABLATION, THE PATIENT BECAME HYPOTENSIVE AND HYPOXEMIC. ALTHOUGH AN EFFUSION WAS DETECTED, THE PHYSICIAN OPTED TO CONTINUE THE PROCEDURE, BASED ON THE SEVERITY. AFTER PVI, CARDIAC MOTION WAS ASSESSED VIA FLUOROSCOPY AND A TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAPHY. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT OUTCOME WAS IMPROVED. THE SOUNDSTAR ECO CATHETER WAS IN THE RIGHT SIDE OF THE HEART. THE CARDIAC TAMPONADE OCCURRED AT THE LEFT SIDE OF THE HEART. THERE WAS NO INFORMATION REGARDING IF THE PATIENT WAS IN SINUS RHYTHM OR ATRIAL FIBRILLATION DURING THE PROCEDURE. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT WAS NOTED THAT THE ADVERSE EVENT MAY HAVE OCCURRED DURING THE ABLATION PHASE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417501 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17636470L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R