BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3071329 · Received April 22, 2013

    Report

    Report Number
    9673241-2013-00122
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED. A REPROCESSED ULTRASOUND CATHETER CONFIRMED THE PERFORATION. A PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THE PATIENT WAS STABILIZED AND WAS UNDER OBSERVATION. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL AND DEFLECTION TESTS. 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 IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). COOLFLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4). STOCKERT 70 SYSTEM, MODEL #: M-5463-01, SERIAL #:(B)(4). 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. BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED. A REPROCESSED ULTRASOUND CATHETER CONFIRMED THE PERFORATION. A PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THE PATIENT WAS STABILIZED AND WAS UNDER OBSERVATION. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT BY THE BWI FIELD REPRESENTATIVE. THE PHYSICIAN HAD COMPLETED VEIN ISOLATION FOR THE LEFT AND RIGHT VEINS. WHEN ATTEMPTING TO RECHECK FOR VEIN CAPTURE VIA PACING FROM THE APPENDAGE, A SHARP 30 POINT DROP IN THE PATIENT'S BLOOD PRESSURE WAS ACKNOWLEDGED BY ANESTHESIA. THE MAPPING CATHETER MAY HAVE PERFORATED THE ENDOCARDIUM. THE EFFUSION WAS CONFIRMED WITH THE REPROCESSED ACCUSOUND CATHETER. THE PHYSICIAN ADMINISTERED A PERICARDIAL TAP REMOVING FLUID WITHIN PERICARDIAL SPACE. THE OTHER FACTOR THAT MAY HAVE CONTRIBUTED TO THE INCIDENT WAS THAT THE PATIENT HAD A FIBROTIC ATRIUM. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. THE USER DID NOT NOTICE ANY ABNORMAL SIGNALS. THE RF GENERATOR WAS SET TO 'POWER-CONTROL" MODE. THE TEMPERATURE CUT-OFF SETTING WAS SET TO 40W AND THE FLOW SETTING WAS SET TO 15ML/MIN. THE AGILIS SHEATH WAS USED. THE ACT WAS MAINTAINED AT 275-350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172222 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-02-S 15813048L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R