BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - LASSO

    MDR report key: 5992430 · Received September 30, 2016

    Report

    Report Number
    2029046-2016-00159
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    August 16, 2016
    Report Date
    September 8, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    NLH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: 8-FR LONG SHEATH (SL0, AF DIVISION, SJM, MINNEAPOLIS, MN, USA), COMPUTER-BASED DIGITAL RECORDING SYSTEM (LABSYSTEM PRO, BARD ELECTROPHYSIOLOGY, LOWELL, MA, USA), 28-MM SECOND-GENERATION CB (ARCTIC FRONT ADVANCE, MEDTRONIC, MINNEAPOLIS, MN, USA), 7FR 20-POLE THREE SITE MAPPING CATHETER (BEEAT, JAPAN-LIFE-LINE, TOKYO, JAPAN), RF NEEDLE (BAYLIS MEDICAL, INC., MONTREAL, QC, CANADA),15-FR STEERABLE SHEATH (FLEXCATH ADVANCE, MEDTRONIC),SPIRAL MAPPING CATHETER (ACHIEVE, MEDTRONIC). (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 6 PATIENT'S WITH PAROXYSMAL ATRIAL FIBRILLATION (PAF) UNDERWENT CRYOTHERMAL PVI AND SUFFERED RIGHT PHRENIC NERVE INJURIES. THE PNIS RESOLVED SPONTANEOUSLY DURING THE PROCEDURE. 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: "PULMONARY VEIN ISOLATION USING A SECOND-GENERATION CRYOBALLOON IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION: ONE-YEAR OUTCOME USING A SINGLE BIG-BALLOON" 108 PATIENTS WERE ENROLLED IN THE STUDY. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE 1-YEAR CLINICAL OUTCOME AFTER SECOND-GENERATION CB ABLATION WITH SINGLE 3-MINUTE FREEZE TECHNIQUES, AND CLINICAL VARIABLES ASSOCIATED WITH AF RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643511 GENERIC - LASSO GENERIC - LASSO NLH BIOSENSE WEBSTER, INC. (IRWINDALE) D-1220-00 UNKNOWN_LASSO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other