BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 4724284 · Received April 23, 2015

    Report

    Report Number
    2029046-2015-00120
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    January 1, 2011
    Report Date
    April 3, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, 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. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT DURING VT PROCEDURE DEVELOPED RETROPERITONEAL BLEEDING FROM FEMORAL ACCESS. THE PHYSICIAN USED SURGICAL EPICARDIAL ACCESS. 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: ¿CATHETER ABLATION OF SCAR-BASED VENTRICULAR TACHYCARDIA: RELATIONSHIP OF PROCEDURE DURATION TO OUTCOMES AND HOSPITAL MORTALITY¿. OBJECTIVES: THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE INFLUENCE OF PROCEDURE DURATION ON OUT COMES AND COMPLICATIONS OVER AN 8-YEAR PERIOD. THERE WERE A TOTAL OF 25 ADVERSE EVENTS (AE) REPORTED IN THIS ARTICLE. 23 OUT 25 AES WERE SERIOUS AND REPORTED SEPARATELY. IN ADDITION, THERE WERE A TOTAL OF 13 DEATH EVENTS, THESE EVENTS REPORTED SEPARATELY. RADIOFREQUENCY ABLATION WAS PERFORMED USING EITHER A 3.5-MM OPEN-IRRIGATED CATHETER (THERMOCOOL) OR A CLOSED-LOOP IRRIGATED CATHETER (CHILLI, BOSTON SCIENTIFIC, (B)(4)). THE AUTHOR DIDN¿T MENTION WHICH ABLATION CATHETER CONTRIBUTED TO THESE EVENTS, THEREFORE BWI IS TAKING A CONSERVATIVE APPROACH REPORTING THESE EVENTS UNDER THE THERMOCOOL CATHETER. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED ON THESE EVENTS TO CLARIFY WHICH CATHETER WAS USED FOR EACH EVENT, HOWEVER THE RESPONSE IS PENDING. ONCE A RESPONSE IS RECEIVED THESE EVENTS WILL BE REASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270112 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other