BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX¿

    MDR report key: 6791844 · Received August 14, 2017

    Report

    Report Number
    2134265-2017-07859
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 19, 2017
    Report Date
    July 21, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RETURNED PRODUCT CONSISTED OF A KINETIX GUIDEWIRE IN THE STERILE POUCH UNOPENED. THE DEVICE WAS VIEWED WITHOUT OPENING THE STERILE POUCH. IT WAS NOTICED THAT THERE WAS A FOREIGN MATERIAL IN THE POUCH. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE ROOT CAUSE HAS BEEN DETERMINED TO BE MANUFACTURING RELATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN MATTER WAS PRESENT INSIDE THE DEVICE PACKAGE. DURING CHECKING OF THE MATERIALS, IT WAS NOTICED THAT A FOREIGN OBJECT WAS NOTED INSIDE THE CONTAINER OF A 185CM 1 PK KINETIX¿ GUIDE WIRE. THE DEVICE NEVER WENT INSIDE THE PATIENT'S BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN MATTER WAS PRESENT INSIDE THE DEVICE PACKAGE. DURING CHECKING OF THE MATERIALS, IT WAS NOTICED THAT A FOREIGN OBJECT WAS NOTED INSIDE THE CONTAINER OF A 185CM 1 PK KINETIX¿ GUIDE WIRE. THE DEVICE NEVER WENT INSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573005 KINETIX¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010 18482144

    Patients

    Seq Age Sex Outcome Treatment
    1