BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER NON - NAVIGATIONAL 4MM (TC)

    MDR report key: 1884317 · Received October 27, 2010

    Report

    Report Number
    2029046-2010-00057
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS KNOWN OBSTRUCTIVE CARDIOMYOPATHY, HEMATOMA, AND AN LVAD DEVICE. THE PATIENT UNDERWENT APPROXIMATELY 5 SURGERIES DURING THIS STAY AND THIS EVENT WAS ONE OF THOSE SURGERIES. ACCORDING TO THE FACILITY AND THE CLINICAL REPRESENTATIVE, THE PATIENT HAD HIS FOURTH LVAD REPLACEMENT, A TRANSECTOMY AND A COUPLE OTHER SURGERIES AFTER THIS EVENT. THE ADVERSE EVENT WAS ATTRIBUTED TO THE PATIENT'S HEALTH CONDITION AND THERE WAS NO MALFUNCTION ASSOCIATED WITH ANY OF THE BWI EQUIPMENT OR PRODUCTS. THE FACILITY DID NOT NOTIFY BIOSENSE WEBSTER OF THIS EVENT AS IT TOOK PLACE ON (B)(6) 2010. THIS INFORMATION WAS RELAYED TO BWI REGULATORY DEPARTMENT BY ANOTHER DOCTOR FROM THE SAME HOSPITAL DURING AN UNRELATED CONVERSATION. UPON RECEIPT OF THIS INFORMATION, A COMPLAINT WAS CREATED FOR THIS EVENT, HOWEVER THE FACILITY HAD REFUSED SERVICE SINCE THERE WAS NO PRODUCT MALFUNCTION AND THE CATHETER INVOLVED IN THE PROCEDURE WAS DISCARDED, THEREFORE, NO ANALYSIS CAN BE PERFORMED. IF THE PRODUCT IS RETURNED TO BWI IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS REQUIRED. CONCOMITANT PRODUCTS: STOCKERT 70 RF GENERATOR, CATALOG # S7001, (B)(4). COOLFLOW® IRRIGATION PUMP, CATALOG # CFP001, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING A BI-DIRECTIONAL CATHETER WHEN ABLATING A PATIENT WITH CARDIOMYOPATHY AND THERE WAS A PERFORATION WHICH RESULTED IN A COMPLICATION. A LEFT VENTRICULAR ASSISTANCE DEVICE WAS DONE AND LATER IT WAS REVERSED. THE SYSTEMS INVOLVED WERE A STOCKERT, COOL FLOW, AND A BI-DIRECTIONAL CATHETER THAT WILL NOT BE RETURNED. THE SERIAL NUMBERS, CATALOG, AND LOT NUMBERS ARE UNKNOWN. THE DATE OF THE EVENT WAS UNKNOWN. FACILITY CONTACT NUMBER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER NON - NAVIGATIONAL 4MM (TC) ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) EZ STEER NON-NAVI 4MM (TC) UNK_EZSTRN-NV(TC)

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| O