BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® NAV ECO CATHETER

    MDR report key: 8140224 · Received December 6, 2018

    Report

    Report Number
    2029046-2018-02420
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 12, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. CONCOMITANT PRODUCTS: 1. NON-BIOSENSE WEBSTER, INC. PRODUCT - 71CM COOK TRANSSEPTAL NEEDLE ; 2. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL SL0 8.5 FR SHEATH; 3. BIOSENSE WEBSTER, INC. PRODUCT - CARTO® 3 SYSTEM, U.S. CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND LASSO® NAV ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTICED A SMALL PERICARDIAL EFFUSION. DURING THE PROCEDURE, PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 600 CC OF FLUID FROM THE PERICARDIUM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. ONE EXTRA DAY OF HOSPITALIZATION WAS REQUIRED FOR MONITORING PURPOSES. PATIENT¿S OUTCOME IS FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. PHYSICIAN STATED THAT THE PERFORATION COULD HAVE OCCURRED EITHER DURING MAPPING WITH A LASSO® NAV ECO CATHETER IN THE RIGHT ATRIUM OR DURING ABLATION WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER TO THE ANTERIOR WALL OF THE LEFT ATRIUM. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A 71 CM COOK TRANSSEPTAL NEEDLE AND A ST. JUDE MEDICAL SL0 8.5 FR SHEATH. GENERATOR WAS USED IN POWER CONTROL MODE AT 30 WATTS. THE POWER DID NOT TITRATE DURING THE PROCEDURE. THE OVERALL TIME FOR ABLATION WAS OVER ONE HOUR AND THE LAST ABLATION CYCLE TIME WAS OF 20-40 SECONDS AT 30 WATTS. THE CATHETER IRRIGATION WAS SET AT 8 CC/MIN. THE PATIENT RECEIVED ANTICOAGULANT (UNSPECIFIED) DURING THE PROCEDURE. THE ACTIVATED CLOTTING TIME (ACT) WAS OF 300-350 SECONDS. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THE CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PATIENT INTERFACE UNIT. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978476 LASSO® NAV ECO CATHETER SIMILAR DEVICE D134901, 510K # K113213 DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R