BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS X?

    MDR report key: 3122822 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03253
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    DRF
    PMA / PMN Number
    K003452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED TREATMENT PROCEDURE THE PACKAGING WAS NOTED TO BE UNSEALED. THE PHYSICIAN OPENED A 2.5MM X 105CM POLARIS X CATHETER AND NOTED THAT THERE WAS NO SEAL ON THE PACKAGING. THE DEVICE DID NOT ENTER THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH AN ANOTHER SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224404 POLARIS X? CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC - SAN JOSE M0047000D0

    Patients

    Seq Age Sex Outcome Treatment
    1