BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS DX STEERABLE DECAPOLAR MAPPING CATHETERS

    MDR report key: 4143640 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-06325
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 4, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    DRF
    PMA / PMN Number
    K924163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED. AN UNSPECIFIED POLARIS DX STEERABLE DECAPOLAR MAPPING CATHETERS WAS SELECTED TO BE ADVANCED TO THE TARGET LESION. DURING RIGHT-SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA (VT) , PATIENT'S BLOOD PRESSURE DROPPED AND PERICARDIAL EFFUSION WAS NOTICED. PERICARDIAL EFFUSION WAS CONFIRMED BY INTENSE CARDIO EXERCISE (ICE). THE PATIENT UNDERWENT SURGERY AND PERICARDIOCENTESIS WAS PERFORMED AND 200 ML OF FLUID WAS REMOVED FROM THE PATIENT. THE PATIENT IS NOW STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624985 POLARIS DX STEERABLE DECAPOLAR MAPPING CATHETERS CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC - SAN JOSE UNK322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention