BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3404931 · Received October 10, 2013

    Report

    Report Number
    0002090040-2013-00015
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 20, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. NO SALES ORDER NUMBER WAS REPORTED SO THE STERILIZATION DATE AND EXPIRATION DATE ARE UNKNOWN. THE COMPLAINT WAS NOT CONFIRMED FOR THE REPORTED FAILURE MODE AS THE DEVICE WAS NOT RETURNED FOR AN EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN; POSSIBLE ROOT CAUSES INCLUDE THE FOLLOWING: PROCESSING ERROR (INCLUDES INSPECTION ERROR). USER ERROR (INCLUDING USER METHODS AND TECHNIQUE). ANCILLARY EQUIPMENT ERROR (INCLUDING ALL EQUIPMENT AND DEVICES OTHER THAN THE COMPLAINT DEVICE). THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING AN ELECTROPHYSIOLOGY CATHETER, "THE TIP BROKE OFF IN THE PATIENT AND WAS LODGED IN THE FEMORAL ARTERY." THE PATIENT WAS TAKEN INTO SURGERY TO REMOVE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517935 NA DRF DRF STRYKER SUSTAINABILITY SOLUTIONS PHOENIX UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention