BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4991824 · Received August 11, 2015

    Report

    Report Number
    9673241-2015-00509
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT AN ATRIAL TACHYCARDIA (AT) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL SUFFERED CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. IT WAS STATED THAT 250 CC FLUID WAS REMOVED FROM THE PATIENT. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS ALSO EVALUATED FOR CARTO 3. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. 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. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE TAMPONADE REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT PRODUCTS: CARTO 3 (S/N: (B)(4)). STOCKERT (S/N: UNKNOWN). COOL FLOW PUMP (S/N: UNKNOWN). PENTARAY CATHETER (CATALOG: D128208, LOT # 17207984L). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT AN ATRIAL TACHYCARDIA (AT) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL SUFFERED CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. IT WAS STATED THAT 250 CC FLUID WAS REMOVED FROM THE PATIENT. A PERICARDIAL EFFUSION WAS NOTICED AFTER PROCEDURE (POST-ABLATION) AS THE PATIENT'S BLOOD PRESSURE DROPPED AND EFFUSION WAS CONFIRMED WITH TRANSTHORACIC ECHOCARDIOGRAM (TTE). THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND REQUIRED ONE DAY EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS ONLY PROCEDURE RELATED; HOWEVER, SINCE THE SMARTTOUCH CATHETER WAS PRESENT DURING THIS PROCEDURE, BWI TAKES CONSERVATIVE APPROACH AND REPORTS THIS EVENT UNDER THE SMARTTOUCH CATHETER. A TRANSSEPTAL PUNCTURE WAS PERFORMED BY USING ST JUDE NEEDLE (BRK 71CM, CATALOG # 407200) AND THE CUSTOMER USED SHEATH: ST JUDE 8.5FR SL1, CATALOG # 406849 DURING THE PROCEDURE. THE CUSTOMER ABLATED AT 30 - 35 WATTS THROUGHOUT THE PROCEDURE, AND TEMPERATURE IN THE HIGH 30'S (NOTHING ABOVE 40 DEGREES NOTED), NORMAL IMPEDANCES IN THE 110-120'S THROUGHOUT THE PROCEDURE. THE COOL FLOW PUMP WAS SET AT 30CC/MIN. NO ANOMALIES WERE FOUND ON THE CATHETER DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523843 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 17217997M

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R