BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4190115 · Received October 21, 2014

    Report

    Report Number
    9673241-2014-00431
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# M-4800-01, SERIAL# 13467). STOCKERT 70 SYSTEM (MODEL# M-5463-01, SERIAL# (B)(4)). COOLFLOW PUMP (MODEL# UNKNOWN, SERIAL# (B)(4)). STRYKER REPROCESSED ACUNAV CATHETER (MODEL# UNKNOWN, LOT# UNKNOWN). REPROCESSED LASSO 2515 (MODEL# D-1290-01-S, LOT# UNKNOWN). MANUFACTURER'S REF. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, FEMALE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. FOUR TO FIVE HOURS FOLLOWING A PROCEDURE ON (B)(6) 2014, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. AN UNKNOWN AMOUNT OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CCU FOR OBSERVATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THERE WAS A TRANSSEPTAL PUNCTURE PERFORMED. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. SETTINGS DURING THE EVENT INCLUDE: POWER MODE / IRRIGATION FLOW SETTING 30ML/MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668368 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S UNK_D-1336-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R