BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THMCL SMTCH SF BID, TC, D-F

    MDR report key: 9778416 · Received March 3, 2020

    Report

    Report Number
    2029046-2020-00341
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    February 7, 2020
    Report Date
    February 7, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL INSPECTION NO VISUAL DAMAGE OR ANOMALIES OBSERVED. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT NON-ISCHEMIC VENTRICULAR TACHYCARDIA - LEFT ABLATION PROCEDURE WITH PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS ALSO REPORTED THAT AFTER TAKING ABOUT 2-3 POINTS FOR FAST ANATOMICAL MAPPING WITH THE PENTARAY, THE CARTO3 SYSTEM WAS DISPLAYING A MAGNETIC DISTORTION ERROR. THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS PLUGGED INTO THE PATIENT INTERFACE UNIT (PIU) AND USED FOR TROUBLESHOOTING JUST PRIOR TO SEEING THE EFFUSION. NO ABLATION WAS PERFORMED. TO TROUBLESHOOT, ALL CATHETERS WERE DISCONNECTED FROM THE PIU AND THE ERROR CLEARED. ONCE THE PENTARAY CATHETER WAS RECONNECTED TO PIU, THE ERROR REAPPEARED. THE PENTARAY CATHETER WAS NOT SHOWING THE SPLINES. THE CABLE WAS EXCHANGED, BUT THE ISSUE PERSISTED. AT THIS TIME THE PERICARDIAL EFFUSION WAS NOTED AND TROUBLESHOOTING WAS STOPPED. THE INTRACARDIAC ECHOCARDIOGRAPHY SOUNDSTAR CATHETER WAS USED TO CONFIRM A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND ABOUT 700 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. PROCEDURE WAS ABORTED AT THE TIME AND PATIENT WENT TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. IT WAS ALSO NOTED THAT THERE WAS NO EFFUSION BEFORE THE PROCEDURE WAS STARTED. THE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER INC. (BWI) PRODUCTS. TRANSSEPTAL WAS PERFORMED USING THE BRK1 NEEDLE. IN THE OPINION OF THE PHYSICIAN THE EVENT WAS PROCEDURE RELATED AND WAS CAUSED DURING TRANSSEPTAL. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION IN THE ICU FOR OBSERVATION WHILE PERICARDIAL DRAINED WAS MAINTAINED AND THEIR CONDITION HAD IMPROVED AS OF (B)(6) 2020 WHEN THE DRAIN WAS REMOVED. NO ABLATION WAS PERFORMED PRIOR TO DISCOVERING THE EFFUSION. SINCE THERE IS NO INDICATION THAT THE ABLATION CATHETER WAS USED FOR ABLATION OR MANIPULATION THE EVENT WILL BE REPORTED UNDER THE PENTARAY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246320 THMCL SMTCH SF BID, TC, D-F CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30296664M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R