BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE DI7TCBLRT, PMA # P030031

    MDR report key: 4495825 · Received February 9, 2015

    Report

    Report Number
    2029046-2015-00034
    Event Type
    Injury
    Date Received
    February 9, 2015
    Date of Event
    November 30, 2014
    Report Date
    January 16, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE, 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. CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO MAPPING SYSTEM US CATALOG # UNKNOWN SERIAL # UNKNOWN PRODUCT: LASSO MAPPING CATHETER US CATALOG # UNKNOWN LOT # UNKNOWN (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE. IT WAS REPORTED THAT CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS WAS OBSERVED IN 7 PATIENTS. THERE WERE NO REPORTED MALFUNCTION WITH ANY OF BWI CATHETERS AND SYSTEMS USED DURING THE CASE. TITLE: ¿SIMPLE MINIMAL SEDATION FOR CATHETER ABLATION OF ATRIAL FIBRILLATION¿ THE OBJECTIVE OF THIS STUDY WAS TO REPORT THE SAFETY AND FEASIBILITY OF MINIMAL SEDATION DURING AF ABLATION. ONE THOUSAND AND FIFTY-TWO AF ABLATION PROCEDURES IN 819 WERE INCLUDED. SUSPECTED DEVICE IS 3.5 MM QUADRIPOLAR ABLATION CATHETER THERMOCOOL. HOWEVER CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN. CARTO MAPPING SYSTEM AND LASSO MAPPING CATHETER WERE ALSO USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92926 SIMILAR DEVICE DI7TCBLRT, PMA # P030031 LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1189-00 UNKNOWN_CELSIUS THERMO TC

    Patients

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