BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6673889 · Received June 28, 2017

    Report

    Report Number
    9673241-2017-00533
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    June 8, 2017
    Report Date
    June 8, 2017
    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 Location
    MN, 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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17651260M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). SMARTABLATE. SMARTABLATE PUMP. WEBSTER CORONARY SINUS WITH AUTO ID CATHETER, MODEL #: D-1353-04-S, LOT #:17649867M. NON BIOSENSE WEBSTER, INC. - BOSTON SCIENTIFIC DX20 (M00420SL21020, (B)(4)). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED HEART BLOCK AV THIRD DEGREE REQUIRING CARDIAC PACEMAKER INSERTION. DURING ABLATION, AN ATRIOVENTRICULAR (AV) BLOCK WAS DETECTED VIA THE INTRACARDIAC SIGNALS AND CONFIRMED VIA THE PRESENCE OF AV DISSOCIATION. PACING VIA THE ABLATION CATHETER WAS INITIATED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. POST-PROCEDURE, A CARDIAC PACEMAKER WAS IMPLANTED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR CARDIAC PACEMAKER INSERTION. PATIENT OUTCOME IS UNCHANGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. 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
    453367 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 17651260M 10846835009194

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R