BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 1013273 · Received March 14, 2008

    Report

    Report Number
    1118880-2008-00004
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - ARE BASED ON THE RETURNED SAMPLE EVAL; IS BASED ON QUALITY RECORD AND RESERVE SAMPLE EVAL. THE TWO INVOLVED DEVICES WERE RETURNED AND EVALUATED. VISUAL EXAMINATION CONFIRMED THAT THE TUBING HAD DETACHED FROM THE INTRODUCER SHEATH HOUSING, ALTHOUGH THERE WAS EVIDENCE OF PROPER BONDING TO THE HOUSING. INSPECTION AND TESTING OF RETENTION SAMPLES CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCT RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. WHILE THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFO, THE RETURNED SAMPLE APPEARANCE IS CONSISTENT WITH SEPARATION DUE TO OVER-PRESSURIZATION OF THE TUBING DURING INJECTION OF CONTRAST MEDIA. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT UNDER CERTAIN CIRCUMSTANCES IN THE WARNINGS/PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE WHICH STATES, "DO NOT USE A POWER INJECTOR THROUGH THE SIDE TUBE AND 3-WAY STOPCOCK." ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SIDE-TUBE DETACHED FROM THE MAIN HOUSING OF TWO INTRODUCER SHEATHS WHILE MAKING AN INJECTION DURING A DIAGNOSTIC PROCEDURE. THE SHEATHS WERE REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. REPORTEDLY, THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS INTRODUCER II KIT INTRODUCER, CATHETER DYB TERUMO MEDICAL CORP. NA HG27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 5FR GUIDE CATHETER