BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HQS INTRODUCER

    MDR report key: 5799737 · Received July 15, 2016

    Report

    Report Number
    3010149375-2016-00002
    Event Type
    Malfunction
    Date Received
    July 15, 2016
    Date of Event
    November 3, 2015
    Report Date
    June 28, 2016
    Manufacturer
    ALSEAL
    Product Code
    DYB
    PMA / PMN Number
    K113849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED ON A SIMILAR DEVICE TO A FDA CLEARED DEVICE. NO SERIOUS INJURY OCCURRED ON THE PATIENT. NONE OF THE AFFECTED DEVICE FROM THIS BATCH WAS ON THE US TERRITORY.

    Description of Event or Problem · 1

    IT WAS INSERTED A 16F INTRODUCER IN ORDER TO INSERT A TRIVASCULAR ENDOPROSTHESIS MOUNTED ON A L4F OD SHAFT. THE AORTIC BODY OF THE PROTHESIS WAS INTRODUCED AND DEPLOYED, AND THEN THE SHAFT (HAS ALSO A ROLE OF INTRODUCER) WAS REMOVED. THE AORTIC LIMB OF THE PROTHESIS WAS INTRODUCED INTO THE AORTIC BODY OF THE PROSTHESIS, THEN DEPLOYED AND REMOVED. AFTER THE STIFF GUIDEWIRE USED TO MOUNT THE PROSTHESIS THE ALSEAL INTRODUCER WAS REMOVED. WHEN THE TIP OF THE INTRODUCER FINALLY CAME OUT OF THE INCISION SITE, THE MD OBSERVED THAT HALF OF THE TIP PARTIALLY DETACHED AND PENDING AND THAT A SMALL PIECE WAS MISSING (NEVER FOUND). THEY WASHED THE INTRODUCER IN ORDER TO OBSERVE BETTER AND AT THAT POINT THE PARTIALLY DETACHED PIECE COMPLETELY DETACHED FROM THE INTRODUCER. SO FAR THE PATIENT HASN'T BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451340 HQS INTRODUCER INTRODUCER CATHETER DYB ALSEAL 2064HQS-16F-300-FDA 14/726

    Patients

    Seq Age Sex Outcome Treatment
    1