BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 4288173 · Received December 1, 2014

    Report

    Report Number
    0002090040-2014-00040
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 3, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLI
    PMA / PMN Number
    K063076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO VISIBLE DAMAGE WAS DETECTED. THE DEVICE INSPECTION INDICATED THAT THE COMPLAINT DEVICE MET ALL INSPECTION AND TEST CRITERIA.ALTHOUGH A THROMBUS WAS DETECTED DURING THE PROCEDURE, IT IS UNKNOWN IF IT WAS DIRECTLY CAUSED BY THE SSS DIAGNOSTIC ULTRASOUND CATHETER. A THROMBUS IS A KNOWN POSSIBLE ADVERSE REACTION TO CARDIAC CATHETERIZATION PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER PRODUCED A POOR IMAGE DURING THE PROCEDURE. A THROMBUS WAS NOTICED AT THE TIP OF THE CATHETER DURING THE PROCEDURE. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS ADMITTED TO ANTICOAGULATION. AFTER TREATMENT, THE PATIENT TESTED NEGATIVE FOR A THROMBUS AND WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775505 NA CATHETER, ANGIOGRAPHY, REPROCESSED NLI STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 10135936 2310207SH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other