BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF BI-DIRECTIONAL CATHETER

    MDR report key: 2963779 · Received February 15, 2013

    Report

    Report Number
    2029046-2013-00019
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. MANUFACTURER'S REF. NO.: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL TACHYCARDIA AFTER PRIOR AF ABLATION PROCEDURE THE PATIENT EXPERIENCED TAMPONADE WHILE USING A NON-BWI MAPPING DEVICE WAS IN USE (VELOCITY-NAVX SYSTEM USED WITH D-F SF CATHETER; PARAMETER SETTING AT 25-30W, 8ML/MIN IN LEFT ATRIUM). ENTRAINMENT AND SIMPLE MAPPING CONFIRMED PERI-MITRAL FLUTTER. THE VEINS WERE ALL ISOLATED. MITRAL VALVE INSUFFICIENCY (MVI) ABLATION CHANGED TO ROOF-DEPENDENT - ABLATED INTO SINUS RHYTHM. BURST PACING PRODUCED ANOTHER ATRIAL TACHYCARDIA WITH EARLIEST ACTIVATION WAS AT ANTEROSEPTAL LEFT ATRIUM NEAR THROMBOSPONDINS (TSP) SITE. THE RF SLOWED TACHYCARDIA BUT NO TERMINATION. WHILST APPLYING CLOCKWISE TORQUE TO MAINTAIN ELECTRICAL CONTACT DURING FURTHER RF (D-F SF CATHETER) NEARER TSP, THE CATHETER APPEARED TO BE DISLODGED TO IN THE RIGHT ATRIUM. DURING ATTEMPTED ROTATIONAL MOVEMENT BACK TOWARDS LEFT ATRIUM, THE DISTAL CATHETER SHAFT WAS RESTRICTED. THE CATHETER WAS WITHDRAWN AND READVANCED EASILY ACROSS SEPTUM INTO LEFT ATRIUM. SUDDEN LOSS OF OUTPUT WAS NOTED (THE BLOOD PRESSURE HAD DROPPED PRIOR TO RE-CROSSING THE SEPTUM). TAMPONADE WAS CONFIRMED, INADVERTENT PERFORATION WAS SUSPECTED (GIVEN RESTRICTED CATHETER MOVEMENT PRIOR TO RETRACTION IT WAS PROBABLY EPICARDIAL). CPR AND SUBXIPHOID PERICARDIOCENTESIS WERE PERFORMED; ANTICOAGULANT WAS REVERSED. THE PATIENT WAS STABILISED BUT LATER FURTHER BLEEDING OCCURRED. EMERGENCY STERNOTOMY TO REPAIR OF LEFT ATRIUM PERFORATION (BETWEEN TSP AND LEFT ATRIUM ROOF NEAR RIGHT PULMONARY VEIN AS SUSPECTED). THE CUSTOMER DID NOT FEEL THERE WAS ANY ISSUE WITH THE DEVICE. NO STEAM POP WAS HEARD OR FELT. DURING SURGERY IT WAS CLEAR THAT THE REGION OF PERFORATED ATRIAL TISSUE WAS QUITE THIN IN PLACES (DESPITE OF UNDERLYING HYPERTROPHIC CARDIOMYOPATHY (HCM) AND EXPECTED ATRIAL HYPERTROPHY). EXTENDED HOSPITAL STAY OF 2 WEEKS (TOTAL RECOVERY TIME). THE PATIENT HAS IMPROVED- NEARLY FULLY RECOVERED AT DISCHARGE. THE UPDATED PATIENT HEALTH STATUS WAS SAID TO BE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68161 THERMOCOOL® SF BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1314-05-S UNKNOWN_D-1314-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R