BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5690470 · Received June 1, 2016

    Report

    Report Number
    9673241-2016-00353
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 13, 2016
    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
    CA
    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. (B)(4). CONCOMITANT PRODUCTS: NON BIOSENSE WEBSTER: ST. JUDE SL1 SHEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIAL TAP. THE PATIENT¿S MEDICAL HISTORY WAS UNKNOWN. THE PATIENT WAS PREPPED AND DRAPED IN THE NORMAL FASHION. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A CHANGE IN THE PATIENT'S BLOOD PRESSURE AND IT WAS CONFIRMED WITH A TRANSTHORACIC ECHO THAT THERE WAS A PERICARDIAL EFFUSION. A PERICARDIAL TAP WAS PERFORMED. THE EVENT OCCURRED DURING THE ABLATION PHASE. AT THE TIME OF THE INCIDENT, THE PHYSICIAN WAS IN THE CORONARY SINUS MAPPING, BUT HAD PREVIOUSLY ABLATED IN THIS AREA. NO TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED. THE GENERATOR WAS SET TO POWER CONTROL MODE. IMPEDANCE RANGED FROM 130-250 OHMS AND POWER WAS IN MANUAL MODE AT 15 AND 20 WATTS. THE LAST ABLATION CYCLE TIME WAS 45 SECONDS AT THE SITE OF INJURY. THE POWER WAS NOT TITRATED DURING ABLATION. THE FLOW SETTING WAS 17ML/MIN DURING ABLATION AND 2ML/MIN FOR LOW FLOW. NO ERRORS WERE NOTED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. IT WAS UNKNOWN IF THE PATIENT RECEIVED ANY ANTICOAGULATION DURING THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346353 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R