BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUMEN BLUESHEATH DELIVERY CATHETER

    MDR report key: 919022 · Received September 19, 2007

    Report

    Report Number
    3004857433-2007-00001
    Event Type
    Malfunction
    Date Received
    September 19, 2007
    Date of Event
    September 11, 2007
    Report Date
    September 19, 2007
    Manufacturer
    ACUMEN MEDICAL, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION OF THE RETURNED DEVICE, IT WAS FOUND THAT A PIECE OF THE RADIOPAQUE TIP 1/16" BY 180 DEGREES OF 8F CATHETER WAS MISSING. THE CAUSE OF THE MISSING PIECE IS NOT KNOWN, HOWEVER, IT IS BELIEVED TO HAVE SEPARATED UPON REMOVAL THROUGH THE SHEATH AS THE PHYSICIAN WAS UNABLE TO FIND THE RADIPAQUE TIP UPON SCANNING THE PATIENT. THE PATIENT DID NOT EXPERIENCE ADVERSE CLINICAL SEQUELAE DUE TO THE MISSING FRAGMENT OF RADIOPAQUE TIP.

    Description of Event or Problem · 1

    AFTER TWO HOURS OF DEVICE USE WITH SIGNIFICANT MANIPULATION, THE DEVICE KINKED AND WAS REMOVED FROM THE PATIENT. UPON REMOVAL IT WAS FOUND THAT A SMALL SECTION OF THE RADIOPAQUE TIP (1/16" BY 180 DEGREES OF 8F CATHETER) WAS MISSING FROM THE DEVICE. THE PHYSICIAN SCANNED THE PATIENT UNDER FLUOROSCOPY, BUT WAS UNABLE TO LOCATE THE RADIOPAQUE TIP. THE PATIENT EXPERIENCED NO ADVERSE EVENTS ASSOCIATED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMEN BLUESHEATH DELIVERY CATHETER INTRODUCER CATHETER DYB ACUMEN MEDICAL, INC. BLS-10-45 H07-0113

    Patients

    Seq Age Sex Outcome Treatment
    1 YR CLOPIDOGREL TO REDUCE THROMBUS FORMATION. BECAUSE| MAY ALSO BE TREATED WITH WAFARIN| THE PATIENT HAS A LOW EF AND AN LV ANEURISM| THE PATIENT WITH BE TREATED WITH ASPIRIN AND