BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR¿ SL-10

    MDR report key: 2181731 · Received July 27, 2011

    Report

    Report Number
    2939204-2011-00384
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQY
    PMA / PMN Number
    K042568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NO ANOMALIES. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE NOTED. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED, IT WAS DETERMINED THAT THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THAT THE DISPENSER HOOP HAD NOT BEEN FLUSHED WITH SALINE PRIOR TO REMOVING THE MICROCATHETER.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE SIDE OF THE CATHETER TIP WAS LEAKING AS IT WAS FLUSHED PRIOR TO PROCEDURE. THE CATHETER WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE SIDE OF THE CATHETER TIP WAS LEAKING AS IT WAS FLUSHED PRIOR TO PROCEDURE. THE CATHETER WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR¿ SL-10 CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M0031681910 13884362

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR