BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STREERABLE TIP CATHETER

    MDR report key: 1233884 · Received November 13, 2008

    Report

    Report Number
    2029046-2008-00037
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 21, 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

    THIS CATHETER IS LABELLED FOR SINGLE USE ONLY. HOWEVER, IT WAS REUSED BY THE FACILITY AND ALSO REUSED ON A DIFFERENT PATIENT. THE REPROCESSED NAVISTAR RMT THERMOCOOL CATHETER RETURNED TO BIOSENSE WEBSTER, THE CATHETER WAS TESTED AND FOUND TO FUNCTION AS EXPECTED. FURTHER INVESTIGATION IS STILL BEING PERFORMED.

    Description of Event or Problem · 1

    IN 2008, THE SAME CATHETER THAT WAS USED ON TWO DAYS EARLIER, WAS REPROCESSED BY THE FACILITY AND IT WAS USED ON A DIFFERENT PATIENT. THIS INJURY REPORTED WAS DURING A LEFT ATRIAL TACHYCARDIA PROCEDURE AND AFTER THE EARLIEST ACTIVATION POINT IN THE RIGHT ATRIUM. A TRANSEPTAL PUNCTURE WAS PERFORMED AND THE LEFT ATRIAL WAS MAPPED AND ABLATION AT THE EARLIEST ACTIVATION POINT TERMINATED THE TACHYCARDIA. TWO TO 3 HOURS AFTER THE PROCEDURE, THE PHYSICIAN WAS INFORMED THAT THE PATIENT HAD LOW BLOOD PRESSURE (75/80 MMHG) WHERE AN ECHOCARDIOGRAPHY WAS PERFORMED AND A 14-MM PERICARDIAL EFFUSION WAS DISCOVERED. SUBXYPHOIDAL PERICARDIAL PUNCTURE WAS PERFORMED WHERE 600 ML OR BLOOD FLUID WAS DRAINED. THERE WAS NO FURTHER ACTIVE BLEEDING AFTERWARDS. THE PATIENT'S HEALTH STATUS WAS REPORTED TO BE GOOD.

    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 72 YR Other