BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6209561 · Received December 28, 2016

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    Report

    Report Number
    9673241-2016-00903
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009194
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 01/05/2017. (B)(4). IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND GENERATOR TEST AND IT WAS FOUND WITHIN SPECIFICATIONS. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS EVALUATED FOR EEPROM, AND THE FUNCTIONALITY OF THE SENSORS OF THE CATHETER WERE TESTED ON THE CARTO 3 SYSTEM. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE FORCE FEATURES WAS EVALUATED AND PASSED. FINALLY, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. 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 SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE CARDIAC TAMPONADE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    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. 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 SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCT: CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL #(B)(4)). SMARTABLATE PUMP. SOUNDSTAR CATHETER (MODEL# M-5723-17 SERIAL# (B)(4)). PENTARAY CATHETER (MODEL# D-1353-04-S LOT# 17566619M). CORONARY SINUS CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, FEMORAL SHEATHS WERE REMOVED AND THE PATIENT¿S BLOOD PRESSURE WAS LOW. A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 300 CC OF FLUID WAS REMOVED. THE PATIENT¿S CONDITION WAS STABLE FOLLOWING THE EVENT. IT IS UNKNOWN IF THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT. THE PATIENT HAS FULLY RECOVERED. THE PHYSICIAN IS UNSURE OF THE CAUSE OF THE EFFUSION. THERE ARE NO NOTED FACTORS WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THE PATIENT RECEIVED HEPARIN; HOWEVER THE ACTIVATED CLOTTING TIME IS UNKNOWN. AN AGILIS SHEATH AND SL1 SHEATH WERE USED DURING THE PROCEDURE. THERE WERE NO ERROR MESSAGES ON ANY BIOSENSE WEBSTER INC. EQUIPMENT DURING THE PROCEDURE. THE LAST ABLATION WAS DONE AT LEAST ONE HOUR PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859750 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 17553140M 10846835009194

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R