BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - LASSO

    MDR report key: 6033694 · Received October 17, 2016

    Report

    Report Number
    2029046-2016-00223
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 22, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    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 WERE USED IN THIS STUDY: RF NEEDLE (BAYLIS MEDICAL, INC., (B)(4)); AN 8-FR LONG SHEATH (SL0, AF DIVISION, SJM, (B)(4)); A 28-MM SECOND GENERATION CB (ARCTIC FRONT ADVANCE, MEDTRONIC, (B)(4)); AN 8-MM TIP CONVENTIONAL CRYOCATHETER (FREEZOR MAX, MEDTRONIC); A 15-FR STEERABLE SHEATH (FLEXCATH ADVANCE, MEDTRONIC); A 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 3 PATIENTS UNDERWENT RADIOFREQUENCY ABLATION PROCEDURE AND HAD RIGHT PHRENIC NERVE INJURIES. 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: "DURABILITY OF CRYOTHERMAL PULMONARY VEIN ISOLATION - CREATING CONTIGUOUS LESIONS IS NECESSARY FOR PERSISTENT ISOLATION." THE PURPOSE OF THIS STUDY AIMED TO EVALUATE THE IMPACT OF THE ABLATION METHOD ON THE DURABILITY OF CRYOTHERMAL PVI. 132 CONSECUTIVE PAROXYSMAL ATRIAL FIBRILLATION PATIENTS UNDERGOING CRYOTHERMAL PVI WERE ENROLLED. SUSPECTED DEVICE IS LASSO; HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER COMPANY'S WERE USED IN THIS STUDY: RF NEEDLE (BAYLIS MEDICAL, INC., (B)(4)); AN 8-FR LONG SHEATH (SL0, AF DIVISION, SJM, (B)(4)); A 28-MM SECOND GENERATION CB (ARCTIC FRONT ADVANCE, MEDTRONIC, (B)(4)); AN 8-MM TIP CONVENTIONAL CRYOCATHETER (FREEZOR MAX, MEDTRONIC); A 15-FR STEERABLE SHEATH (FLEXCATH ADVANCE, MEDTRONIC); A SPIRAL MAPPING CATHETER (ACHIEVE, MEDTRONIC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685298 GENERIC - LASSO GENERIC - LASSO DRF BIOSENSE WEBSTER, INC. (IRWINDALE) D-1220-00 UNKNOWN_LASSO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other