BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY CATHETER

    MDR report key: 2911890 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16660
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN ATTEMPT TO CANNULATE THE CORONARY SINUS USING THIS CATHETER, THE PATIENT SUFFERED AN AIR EMBOLUS. THE PHYSICIAN FELT THE VALVE WAS CLOSED ON THE CATHETER AND DOES NOT THINK THE CATHETER WAS THE ISSUE, HOWEVER, THE CAUSE FOR THE AIR EMBOLUS COULD NOT BE DETERMINED. THE CATHETER WAS DISCARDED AND THEREFORE WILL NOT BE RETURNED FOR ANALYSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19114 ACUITY CATHETER GUIDE CATHETER DYB EXTERNAL MANUFACTURER 7008

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R