BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1032231 · Received April 18, 2008

    Report

    Report Number
    9681834-2008-00009
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K955801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL HAS NOT RETURNED THE SAMPLE AS OF THIS TIME. HOWEVER, 2 PHOTOGRAPHS OF THE DEVICE HAVE BEEN PROVIDED. UNFORTUNATELY, THE TIP OF THE DEVICE IS OUT OF FOCUS SUCH THAT THE COATING DAMAGE PARTIALLY EXPOSING THE CORE WIRE WAS CONFIRMED, BUT NO OTHER SIGNIFICANT INFO CAN BE OBTAINED FROM EXAMINATION OF THE PICTURES. THEREFORE, MEANINGFUL INVESTIGATION WAS LIMITED TO ASSESSMENT OF THE USER FACILITY'S EVENT DESCRIPTION, QUALITY RECORDS AND RETAINED SAMPLES. EVAL OF A RESERVE SAMPLE FROM THE REPORTED LOT CONFIRMED THERE WERE NO ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE CAUSE CANNOT BE DEFINITIVELY DETERMINED, THE EVENT DESCRIPTION AND PHOTOGRAPHIC APPEARANCE ARE CONSISTENT WITH DAMAGE TO THE GLIDEWIRE DUE TO MANIPULATION AGAINST A SHARP AND/OR HARD SURFACE DURING USE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE WARNINGS/PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATING THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS "MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL." IN ADDITION, THE IFU STATES, "WHEN USING A DRUG OR A DEVICE CONCURRENTLY WITH THE GLIDEWIRE, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE GLIDEWIRE." ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. PATIENT CODE: 2199 - NOT LABELED. DEVICE CODES: 1628, 1104 - LABELED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PART OF THE GUIDEWIRE'S OUTER COATING "BROKE OFF" PARTIALLY EXPOSING THE WIRE CORE DURING A CEREBRAL ANGIOGRAM PROCEDURE. REPORTEDLY, THE GUIDEWIRE WAS REMOVED FROM THE PT AND PLACED IN A BOWL OF SOLUTION TO MAINTAIN PROPER LUBRICITY. WHEN THE PHYSICIAN WENT TO RE-INSERT THE DEVICE HE NOTICED THE DISTAL TIP OF THE CORE WIRE "WAS EXPOSED." THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY WITH ANOTHER GUIDEWIRE. DURING FOLLOW-UP COMMUNICATION, THE USER FACILITY CONTACT STATED THAT THE PIECE OF DETACHED COATING WAS DISCARDED IN THE TRASH, THE CLINICIAN DETERMINED THAT NO MEDICAL INTERVENTION WAS NEEDED IN RELATION TO THE DAMAGED GUIDEWIRE AND THAT THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 071120

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK