BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL

    MDR report key: 6891998 · Received September 25, 2017

    Report

    Report Number
    9673241-2017-01098
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    July 31, 2017
    Report Date
    September 1, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED] BY THE CUSTOMER. CONCOMITANT PRODUCTS THAT USED IN THIS STUDY: LASSO CATHETER, CARTO. OTHER COMPANIES DEVICES THAT WERE USED IN THE STUDY: TRANSSEPTAL SHEATHS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT A TOTAL OF 124 PATIENTS WITH AF PERSISTENCE UNDERWENT ABLATION BETWEEN MARCH 2008 AND FEBRUARY 2017. SIXTY-ONE PATIENTS WERE RANDOMIZED TO THE PVI-ONLY GROUP AND 57 PATIENTS TO THE SUBSTRATE-MODIFICATION GROUP. AMONG THEM, TWO PATIENTS WITH SUBSTRATE MODIFICATION GROUP DEVELOPED A CARDIAC TAMPONADE. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿STAND-ALONE PULMONARY VEIN ISOLATION VERSUS PULMONARY VEIN ISOLATION WITH ADDITIONAL SUBSTRATE MODIFICATION AS INDEX ABLATION PROCEDURES IN PATIENTS WITH PERSISTENT AND LONG-STANDING PERSISTENT ATRIAL FIBRILLATION¿ THE PROSPECTIVE AND RANDOMIZED (B)(6) SOUGHT TO ASSESS, IN PATIENTS WITH PERSISTENT AND LONGSTANDING PERSISTENT AF, THE MIDTERM OUTCOMES AFTER INDEX ABLATION STRATEGIES OF STAND-ALONE PVI OR A STEPWISE APPROACH OF PVI FOLLOWED BY CFAE AND LINEAR ABLATION. SUSPECT DEVICE IS A STANDARD IRRIGATED-TIP 3.5-MM-TIP ABLATION IRRIGATED RADIOFREQUENCY CATHETER, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671458 SMART TOUCH BIDIRECTIONAL SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R