BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STREERABLE TIP CATHETER

    MDR report key: 1233866 · Received November 13, 2008

    Report

    Report Number
    2029046-2008-00036
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031/S5
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DAYS LATER (2008), THE SAME CATHETER THAT WAS REPROCESSED BY THE FACILITY WAS USED DURING A LEFT ATRIAL TACHYCARDIA PROCEDURE ON A DIFFERENT PATIENT. ECHOCARDIOLOGRAPHY WAS PERFORMED AND A 14-MM PERICARDIAL EFFUSION WAS DISCOVERED. THIS INJURY IS REPORTED UNDER MANUFACTURER'S REF. NO. THE REPROCESSED NAVISTAR RMT THERMOCOOL CATHETER RETURNED TO BIOSENSE WEBSTER WAS TESTED AND FOUND TO FUNCTION AS EXPECTED. FURTHER INVESTIGATION IS STILL BEING PERFORMED. THIS REPORT IS RELATED TO BIOSENSE WEBSTER ANOTHER THREE MANUFACTURER'S REF. NUMBERS.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED PERICARDIAL EFFUSION AFTER ABLATION OF ATRIAL FIBRILLATION. THE PATIENT WAS ASYMPTOMATIC AND THE PERICARDIAL EFFUSION WAS DISCOVERED 1 DAY AFTER THE ABLATION PROCEDURE DURING A ROUTINE ECHOCARDIOGRAPHY EXAMINATION. FURTHER ECHOCARDIOGRAPHIC CONTROLS SHOWED REGRESSION OF THE PERICARDIAL EFFUSION. THE PATIENT HAD AN UNEVENTFUL HOSPITAL STAY AND WAS DISCHARGED IN GOOD CONDITION FROM THE FACILITY. THE PATIENT DID NOT NEED PERICARDIAL PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STREERABLE TIP CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION CATHETER OAD BIOSENSE WEBSTER, INC. (IRWINDALE) D-1266-01-S UNKNOWN_D-1266-

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR