BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2250476 · Received September 15, 2011

    Report

    Report Number
    9673241-2011-00096
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER WAS TESTED AND PASSED DEFLECTION, ELECTRICAL, LEAKAGE, TEMPERATURE AND STOCKERT GENERATOR TESTS. ALSO, IT WAS EVALUATED VISUALLY AND IT WAS IN GOOD CONDITION WITH NO DAMAGES. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED AS THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    UPON FOLLOW-UP WITH THE CUSTOMER FACILITY, THE CUSTOMER FACILITY CONFIRMED THAT THEY DO NOT CONSIDER THE BWI EQUIPMENT OR PRODUCTS TO BE THE CAUSE OF THE PATIENT INCIDENT. CUSTOMER DECLINED TO HAVE THE BWI EQUIPMENT FUNCTIONAL TESTED. CUSTOMER WITH CONTINUE TO USE THE BWI EQUIPMENT. THE CUSTOMER FACILITY DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT, PRODUCT, OR THE PROCEDURE. IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE CUSTOMER FACILITY DURING THE COMPLAINT INVESTIGATION, A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA AS REQUIRED. CONCOMITANT DEVICES: CARTO 3 SYSTEM, CATALOG # FG540000, (B)(4); STOCKERT 70 RF GENERATOR, CATALOG # S7001, (B)(4); COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, (B)(4); LASSO 2515 NAV VARIABLE CATHETER, CATALOG # LN222515CT, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND REQUIRED MEDICAL INTERVENTION. FOLLOWING TRANSSEPTAL ACCESS, PERFORMED UNDER ULTRASOUND AND WITHOUT FLUOROSCOPY, THE BLOOD PRESSURE DROPPED AND ULTRASOUND WAS USED TO IDENTIFY AN EFFUSION IN THE PERICARDIAL SPACE. A PERICARDIOCENTESIS WAS PERFORMED AND THE EFFUSION WAS DRAINED. THE PATIENT WAS STABILIZED AND WILL REMAIN IN THE HOSPITAL FOR OBSERVATION. THE CASE WAS NOT COMPLETED. THE CUSTOMER ALSO INDICATED THAT SOME REPROCESSED ULTRASOUND AND DIAGNOSTIC CATHETERS (NON BWI CATHETERS) WERE ALSO IN USE BUT NO ADDITIONAL DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15400220M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R