BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-SHUTTLE RF GENERATOR

    MDR report key: 1233885 · Received November 13, 2008

    Report

    Report Number
    9612355-2008-00022
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 20, 2008
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE 2 OTHER CARDIAC PERFORATIONS REPORTED BY THE FACILITY USING ANOTHER MANUFACTURER'S CATHETERS. NO FURTHER INFORMATION IS AVAILABLE ON THE PATIENTS AND EVENT DETAILS.

    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. TWO DAYS LATER, THE SAME CATHETER THAT WAS REPROCESSED BY THE FACILITY 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 A ECHOCARDIOLOGRAPHY WAS PERFORMED AND A 14 MM PERICARDIAL EFFUSION WAS DISCOVERED. SUBXYPHOIDAL PERICARDIAL PUNCTURE WAS PERFORMED WHERE 600 ML OF 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 EP-SHUTTLE RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R