BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HQS INTRODUCER

    MDR report key: 5799722 · Received July 15, 2016

    Report

    Report Number
    3010149375-2016-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2016
    Date of Event
    January 14, 2016
    Report Date
    June 28, 2016
    Manufacturer
    ALSEAL
    Product Code
    DYB
    PMA / PMN Number
    K113849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE MALFUNCTION RESULTED IN A REMOVAL ACTION OF 10 AFFECTED UNITS WHICH WERE DISTRIBUTED TO THE INITIAL IMPORTER. THESE 10 UNITS HAVE BEEN DESTROYED ONSITE BY ALSEAL SALES REPRESENTATIVE ON (B)(6) 2016. NONE OF THESE AFFECTED DEVICES HAVE REACHED U.S. FINAL USERS, THEY WERE ONLY AT THE INITIAL IMPORTER STOCK.

    Description of Event or Problem · 1

    AN HQS INTRODUCER CATHETER, REF. (B)(4), LOT NUMBER 15/114 WAS USED AT THE (B)(6), ACCORDING TO ITS INTENDED USE. DURING THE CLINICAL PROCEDURE, AND WHILE REMOVING THE HQS SHEATH, IT WAS NOTICED THAT A PART OF ITS EXTREMITY WAS BROKEN. THE BROKEN PART WAS EASILY RETRIEVED DURING REMOVAL OF THE HQS BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451070 HQS INTRODUCER INTRODUCER CATHETER DYB ALSEAL 2064HQS-20F-200-FDA 15/114

    Patients

    Seq Age Sex Outcome Treatment
    1