BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 4461330 · Received January 28, 2015

    Report

    Report Number
    9673241-2015-00042
    Event Type
    Injury
    Date Received
    January 28, 2015
    Date of Event
    January 31, 2012
    Report Date
    January 12, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION: "...TOTAL OF 2 PATIENTS DEVELOPED PULMONARY VEIN STENOSIS. ONE PATIENT DEVELOPED STENOSIS AFTER 1ST OR SECOND PROCEDURE, WHICH REQUIRED INTERVENTION. ANOTHER PATIENT HAD ASYMPTOMATIC CLINICAL COURSE. TWO PATIENT DEVELOPED PSEUDOANEURYSM. TOTAL OF 8 PATIENTS HAD ARTEROVENOUS FISTULA. 6 OUT OF 8 AFTER HAD FISTULA AFTER FIRST OR SECOND CARDIAC ABLATION PROCEDURE AND 2 OUT OF 8 DEVELOPED FISTULA AFTER THIRD OR GREATER PROCEDURE. TOTAL OF 2 PATIENTS HAD LARGE HEMATOMA. ONE PATIENT HAD HEMATOMA AFTER FIRST OR SECOND CARDIAC ABLATION PROCEDURE AND ANOTHER PATIENT AFTER THIRD OR GREATER PROCEDURE. ONE PATIENT HAD AIR EMBOLISM WITH TRANSIENT ST CHANGES; ONE PATIENT HAD FLUID OVERLOAD. THIS PATIENT REQUIRED PROLONG HOSPITALIZATION. LASSO CATHETER WAS USED FOR PV MAPPING. HOWEVER CATALOG NUMBER AND LOT NUMBER ARE NOT AVAILABLE. THE AUTHOR DIDN¿T MENTION WHAT ABLATION CATHETER WAS USED DURING PVI PROCEDURE." THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER APPROVED UNDER 510(K) P030031/(B)(4). CONCOMITANT BWI PRODUCT: PRODUCT: LASSO CATHETER, US CATALOG # UNKNOWN, LOT # UNKNOWN. THE PRODUCT IS NOT AVAILABLE, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. (B)(4). 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 TOTAL OF 2 PATIENTS HAD RETROPERITONEAL BLEEDING. ONE PATIENT HAD BLEEDING AFTER FIRST OR SECOND CARDIAC ABLATION PROCEDURE AND ANOTHER ONE AFTER THIRD OR GREATER PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS CONFIRMED BY THE AUTHOR, THAT CHILLI (BOSTON SCIENTIFIC) OR THERMOCOOL ABLATION CATHETERS WERE USED DURING THIS TRIAL. SINCE IT IS IMPOSSIBLE TO DETERMINE WHAT PRODUCT WAS USED DURING THIS CASE, BWI IS TAKING A CONSERVATIVE APPROACH, THEREFORE THE EVENT WILL BE REPORTED UNDER THE THERMOCOOL CATHETER. BASED ON THE FACTS OF THESE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE CATHETERS AND SYSTEMS USED DURING THIS TRAIL. THUS, THESE EVENT ARE UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿ ELECTROPHYSIOLOGIC FINDINGS AND LONG-TERM OUTCOMES IN PATIENTS UNDERGOING THIRD OR MORE CATHETER ABLATION PROCEDURES FOR ATRIAL FIBRILLATION¿. THE AIM OF THIS STUDY WAS TO CHARACTERIZE THE FINDINGS OF THE ARRHYTHMOGENIC SOURCES, STATUS OF THE PVS, AND REPORT THE LONG-TERM OUTCOME (>12 MONTHS) FROM THE LAST PROCEDURE USING A CONSISTENT ABLATION STRATEGY AT 3RD AND 4TH ABLATION. THE STUDY WAS CONDUCTED FROM NOVEMBER 2000 TO JANUARY 2012. FROM THIS REPORT THERE WERE OTHER ADVERSE EVENTS: TOTAL OF 7 PATIENTS HAD CARDIAC TAMPONADE. 4 OUT OF 7 DEVELOPED TAMPONADE AFTER FIRST OR SECOND CARDIAC ABLATION PROCEDURE AND 3 OUT OF 7 DEVELOPED CARDIAC TAMPONADE AFTER THIRD OR GREATER PROCEDURE. THERE IS NO CLAIM OF PRODUCT MALFUNCTION. TOTAL OF 3 PATIENTS HAD CEREBROVASCULAR ACCIDENT (CVA). 2 OUT OF 3 DEVELOPED CVA AFTER FIRST OR SECOND CARDIAC ABLATION PROCEDURE AND 1 OUT OF 3 DEVELOPED CVA AFTER THIRD OR GREATER PROCEDURE. THERE IS NO CLAIM OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64313 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER SIMILAR DEVICE D131501, PMA # P030031/S034 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-00 UNKNOWN_D-1315-00

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening LASSO CATHETER