BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY CATHETER

    MDR report key: 3211338 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07635
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS BREAK AWAY CATHETER WAS DISCARDED AND WILL NOT BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT, WHILE TRYING TO ROTATE THIS BREAK AWAY INNER CATHETER IN A VESSEL TO SELECT THE TARGET VESSEL, THIS CAUSED A DISSECTION. THERE WAS CONCERN THIS WAS TO THE DESIGN OF THE TIP AFTER THE CURVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE DISSECTION. AN ULTRASOUND WILL BE PERFORMED TO CONFIRM THERE WAS NO FURTHER BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310113 ACUITY CATHETER GUIDE CATHETER DYB EXTERNAL MANUFACTURER 7063

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R