BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8110830 · Received November 28, 2018

    Report

    Report Number
    2029046-2018-02370
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    October 30, 2018
    Report Date
    October 30, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835008982
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. 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 SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# UNKNOWN, SERIAL# UNKNOWN). LASSO D -CURVE CATHETER (MODEL# UNKNOWN, LOT# UNKNOWN). ABBOTT BRK-1 TRANSSEPTAL NEEDLE (MODEL# 407201, LOT# UNKNOWN). ABBOTT SL1 8.5F SHEATHS (MODEL# 407453, LOT# UNKNOWN) QTY:2. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND MEDICATION. DURING THE ABLATION PHASE, CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 800 ML OF FLUID FROM THE PERICARDIUM. MEDICATION ("PROTAMAMIN" SULFATE AND OCTAPLEX) WAS ADMINISTERED. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PATIENT¿S ANATOMY WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. (BWI) EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL NEEDLE WAS PERFORMED WITH AN ABBOTT BRK-1 TRANSSEPTAL NEEDLE (407201) AND TWO ABBOTT SL1 8.5F SHEATHS (407453). THE CATHETER IRRIGATION WAS SET AT 17ML/MIN. THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH AN ACTIVATED CLOTTING TIME (ACT) OF 296 SECONDS. THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WAS IN CLOSE PROXIMITY TO LASSO D CURVE CATHETER. THE CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE FORCE VISUALIZATION FEATURE USED WAS VISITAG. THE PARAMETERS FOR STABILITY THAT WERE USED WERE 3G, 3 SECONDS, 25% OF TIME, ABLATION INDEX 350 POST, AND 450 ANTERIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950025 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30051386M 10846835008982

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R