BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3071095 · Received April 22, 2013

    Report

    Report Number
    9673241-2013-00117
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4); STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4); COOL FLOW PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4); LASSO CATHETER: MODEL #: D-1343-01-S, LOT #: 15802495L. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE IT WAS REPORTED THERE WAS A HIGH IMPEDANCE ON THE STOCKERT DURING ABLATION TOWARDS THE END OF THE CASE. AFTER A COUPLE OF MINUTES THE PATIENT'S BLOOD PRESSURE DROPPED. EPINEPHRINE WAS GIVEN TO THE PATIENT IMMEDIATELY TO BRING THE BLOOD PRESSURE BACK. ULTRASOUND SCAN AND TRANSTHORACIC ULTRASOUND CONFIRMED PERFORATION ON THE LEFT ATRIUM. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 400 CC OF FLUID WAS REMOVED. THE PATIENT WAS STABILIZED AND UNDER OBSERVATION. ADDITIONAL INFORMATION PROVIDED STATED THE PHYSICIAN STATED THERE MAY HAVE BEEN A POUCH IN THE ROOF THAT MAY HAVE BEEN SUSCEPTIBLE TO TOO MUCH ABLATING WHICH MIGHT CONTRIBUTE TO THE CARDIAC PERFORATION/TAMPONADE EVENT. IT WAS UPDATED THE PATIENT WAS OBSERVED. ANOTHER TRANSTHORACIC ULTRASOUND PERFORMED AND NO MORE EFFUSION WAS FOUND. PATIENT WAS IN GOOD HEALTH AND WAS SENT HOME ON (B)(6). THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. 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. COOL FLOW PUMP TEST WAS PERFORMED AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. 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 PERFORATION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THERE WAS A HIGH IMPEDANCE ON THE STOCKERT DURING ABLATION TOWARDS THE END OF THE CASE. AFTER A COUPLE OF MINUTES THE PATIENT'S BLOOD PRESSURE DROPPED. EPINEPHRINE WAS GIVEN TO THE PATIENT IMMEDIATELY TO BRING THE BLOOD PRESSURE BACK. ULTRASOUND SCAN AND TRANSTHORACIC ULTRASOUND CONFIRMED PERFORATION ON THE LEFT ATRIUM. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 400 CC OF FLUID WAS REMOVED. THE PATIENT WAS STABILIZED AND UNDER OBSERVATION. ADDITIONAL INFORMATION PROVIDED STATED THE PHYSICIAN STATED THERE MAY HAVE BEEN A POUCH IN THE ROOF THAT MAY HAVE BEEN SUSCEPTIBLE TO TOO MUCH ABLATING WHICH MIGHT CONTRIBUTE TO THE CARDIAC PERFORATION/TAMPONADE EVENT. IT WAS UPDATED THE PATIENT WAS OBSERVED. ANOTHER TRANSTHORACIC ULTRASOUND PERFORMED AND NO MORE EFFUSION WAS FOUND. PATIENT WAS IN GOOD HEALTH AND WAS SENT HOME ON (B)(6) 2113.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172545 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-05-S 15797557L

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R