BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SF CARTO 3,F-J,TC

    MDR report key: 9345866 · Received November 20, 2019

    Report

    Report Number
    2029046-2019-03903
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835003260
    PMA / PMN Number
    P030031/S025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. WE ARE WORKING ON THE MANUFACTURE RECORD EVALUATION (MRE), ONCE WE GET MORE INFORMATION IT WILL BE SUBMITTED IN THE SUPPLEMENTAL. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REF NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER MAPPING AND ABLATING FROM THE RETROGRADE AORTIC APPROACH, THE PHYSICIAN OBTAINED TRANSSEPTAL ACCESS TO CONTINUE. AT THE END OF THE PROCEDURE, A DROP IN BLOOD PRESSURE WAS NOTICED. CARDIAC TAMPONADE WAS CONFIRMED USING INTRACARDIAC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED REMOVING 220 CC OF FLUID FROM AROUND THE PATIENT'S HEART. PATIENT WAS LEFT WITH A DRAIN IN PLACE. THE PATIENT'S BLOOD PRESSURE STABILIZED, AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT CONDITION IMPROVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY FOR THE EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THE FLOW SETTING WAS SET TO STANDARD SETTINGS. THERE WAS NO EVIDENCE OF STEAM POP DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141935 THERMOCOOL SF CARTO 3,F-J,TC CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835003260

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R