BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4130212 · Received September 30, 2014

    Report

    Report Number
    2029046-2014-00346
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    May 5, 2009
    Report Date
    July 23, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FROM THE REPORT THERE WERE 13 (THIRTEEN) PATIENTS WITH SERIOUS ADVERSE EVENTS (THESE EVENTS WILL BE REPORTED SEPARATELY): PATIENT # 1 ((B)(6)): TRANSIENT ISCHEMIC ATTACK /PERICARDIAL EFFUSION/LOWER RESPIRATORY TRACT INFECTION. PATIENT # 2 ((B)(6)): CEREBROVASCULAR ACCIDENT/DEATH; PATIENT #3 ((B)(6)): RETROPERITONEAL BLEED; PATIENT #4 ((B)(6)): RETROPERITONEAL BLEED; PATIENT #5 ((B)(6)):MAJOR PULMONARY VEIN STENOSIS; PATIENT #7 ((B)(6)): LOWER RESPIRATORY TRACT INFECTION; PATIENT #8 ((B)(6)): TAMPONADE; PATIENT #10 ((B)(6)): MINOR PULMONARY VEIN STENOSIS; PATIENT #16 ((B)(6)): LOWER RESPIRATORY TRACT INFECTION; PATIENT #20 ((B)(6)): PERICARDIAL EFFUSION/ LOWER RESPIRATORY TRACT INFECTION. PER THE ARTICLE, OTHER NON-SERIOUS AE¿S WERE ALSO REPORTED: 6 PERICARDIAL EFFUSION; 8 HEMATOMA; 1 PULMONARY VEIN STENOSIS. THESE EVENTS ARE NOT KNOWN TO HAVE REQUIRED INTERVENTION/TREATMENT NOR EXTENDED HOSPITALIZATION STAY. THERE IS A DEATH EVENT AND NO BWI DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION.

    Description of Event or Problem · 1

    "BIOSENSE WEBSTER REVIEWED "RANDOMIZED TRIAL COMPARING ROBOTIC TO MANUAL ABLATION FOR ATRIAL FIBRILLATION, HEART RHYTHM" ARTICLE AND UPON FOLLOWING UP WITH THE CUSTOMER, BWI RECEIVED ADDITIONAL INFORMATION ON (B)(4) 2 2014. THIS COMPLAINT IS BEING OPENED FOR THE PROCEDURE CONDUCTED ON (B)(6) 2009. THE PATIENT SUFFERED FROM CARDIAC TAMPONADE. HOWEVER IT'S UNKNOWN THE PATIENT UNDERWENT ADDITIONAL SURGERY. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE THERMOCOOL CATHETER. PER A REPORT IN THE JOURNAL OF HEART RHYTHM, A SINGLE-CENTER RANDOMIZED STUDY WAS CONDUCTED ON 157 PATIENTS, BY (B)(6)HOSPITAL, TO ASSESS THE IMPACT OF REMOTE ROBOTIC NAVIGATION ON ONE YEAR SINGLE-PROCEDURE SUCCESS RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607631 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR THERMOCOOL UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening