BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4

    MDR report key: 2030018 · Received March 25, 2011

    Report

    Report Number
    2939204-2011-00138
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL ASSEMBLY AND PERFORMANCE SPECIFICATIONS. INSPECTION OF THE RETURNED DEVICE FOUND NO ANOMALIES TO THE DEVICE, THERE WAS NO COATING PEELING AT THE DISTAL TIP. THE REPORT EVENT WAS NOT CONFIRMED. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS NOTED THAT THE COATING WAS PEELING FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS NOTED THAT THE COATING WAS PEELING FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M003468150 13526774

    Patients

    Seq Age Sex Outcome Treatment
    1