BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC-EZ STEER TCOOL NON NAV

    MDR report key: 4096714 · Received September 17, 2014

    Report

    Report Number
    9673241-2014-00354
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    December 1, 2013
    Report Date
    August 20, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER (B)(4): PULMONARY EVENTS (4), VASCULAR ACCESS EVENTS (6). ONE CASE OF STENOSIS OF THE LEFT INFERIOR PV WILL BE REPORT SEPARATELY UNDER COMPLAINT # (B)(4), 1 ESOPHAGEAL INJURY AND 1 CARDIAC TAMPONADE SUBSEQUENT TO A REPEAT ABLATION PROCEDURE OCCURRED AT MORE THAN 7 DAYS FOLLOW-UP. THERE ADVERSE EVENT WERE ALREADY REPORTED UNDER REPORT # 9673241-2014-00350 ON 9/15/2014. THERE WERE NO DEVICE OR PROCEDURE RELATED DEATHS IN THESE REGISTRIES, AS REVIEWED AND ADJUDICATED BY THE INDEPENDENT SAFETY MONITORING COMMITTEE. THERE ARE NO DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL SF CATHETER. CONCOMITANT PRODUCTS: CARTO3 MAPPING SYSTEM WAS USED FOR THE PROCEDURES.

    Description of Event or Problem · 1

    IN AN ARTICLE WHICH BIOSENSE WEBSTER ALREADY REPORTED UNDER REPORT # 9673241-2014-00350 ON 9/15/2014, AFTER RE-REVIEWING THIS ARTICLE, SPECIFIC INFORMATION WAS FOUND ABOUT THE FOLLOWING PATIENT WHO SUFFERED AN PV STENOSIS, THEREFORE, THIS REPORT WILL BE SUBMITTED TO DOCUMENT THIS PATIENT'S SPECIFIC INJURY: THE PATIENT WITH PV STENOSIS WAS A (B)(6)-YEAR-OLD MALE WITH MULTIPLE COMORBID CONDITIONS. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED APPROXIMATELY 80% STENOSIS OF THE LEFT INFERIOR PV AND 40¿50% STENOSIS OF THE LEFT SUPERIOR PV. BOTH VEINS WERE SUCCESSFULLY STENTED AT 7 MONTHS POSTABLATION. THE ORIGINAL ARTICLE WAS: ARTICLE TITLE: ACUTE SAFETY OF AN OPEN-IRRIGATED ABLATION CATHETER WITH 56-HOLE POROUS TIP FOR RADIOFREQUENCY ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION: ANALYSIS FROM 2 OBSERVATIONAL REGISTRY STUDIES. PER A REPORT IN THE JOURNAL OF CARDIOVASC ELECTROPHYSIOL. 2014 AUG;25(8):852-8. DOI: 10.1111/JCE.12403. EPUB 2014 APR 9, A MULTI-CENTER STUDY WAS CONDUCTED ON 742 ENROLLED PATIENTS FROM 2 REGISTRIES (SFAF = 508, IUAF = 234), BY OZA S. OF THE ATRIAL FIBRILLATION INSTITUTE, ST. VINCENT¿S MEDICAL CENTER, JACKSONVILLE, FLORIDA ET AL., TO REPORT REAL WORLD ACUTE SAFETY DATA FROM 2 PROSPECTIVE US OBSERVATIONAL REGISTRY STUDIES USING THE POROUS TIP CATHETER FOR THE TREATMENT OF DRUG REFRACTORY, RECURRENT, SYMPTOMATIC PAROXYSMAL AF. A SECONDARY OBJECTIVE OF THIS PAPER IS TO REPORT ON ANY DIFFERENCES IN ACUTE SAFETY BETWEEN PATIENTS AGE 65 AND OLDER AND YOUNGER PATIENTS. FOLLOW-UP TIME INFORMATION: 7 DAYS OF FOLLOW-UP DATA IN ONE STUDY AND AT LEAST 120 DAYS OF DATA FROM A 1-YEAR FOLLOW-UP IN THE OTHER. FROM THE REPORT THERE WERE 36 PROCEDURE OR DEVICE-RELATED ACUTE SERIOUS ADVERSE EVENTS: ABDOMINAL PAIN (1), ACUTE CORONARY SYNDROME (1), ANEMIA (1), CARDIAC TAMPONADE/PERFORATION (9), CONGESTIVE HEART FAILURE (1), DYSPHAGIA (1), HEMATURIA (1), HYPONATREMIA (1), HYPOTENSION (1), NONCARDIAC CHEST PAIN (1), PERICARDITIS (5)...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576292 GENERIC-EZ STEER TCOOL NON NAV CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB BIOSENSE WEBSTER, INC. (JUAREZ) GENERIC-EZ STEER TCOOL NON NAV UNKNOWN_EZ_STEER_TC_NNAV

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R