BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1061766 · Received June 13, 2008

    Report

    Report Number
    9681834-2008-00013
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K955801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE USER FACILITY INFORMATION, NON-RESORBABLE MATERIAL WAS LEFT UNRETRIEVED IN THE PATIENT'S BODY. THE INVOLVED DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS CONDUCTED BASED ON A REVIEW OF INFORMATION PROVIDED BY USER FACILITY AND MANUFACTURING QUALITY RECORDS. CONCLUSIONS - IS BASED UPON EVALUATION OF USER FACILITY INFORMATION. FOLLOW-UP COMMUNICATION CONFIRMED THAT THE USER FACILITY DOES NOT THINK THIS EVENT WAS RELATED TO THE MANUFACTURE OR PERFORMANCE OF THE DEVICE. 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 IS CONSISTENT WITH DAMAGE TO THE GLIDEWIRE DUE TO MANIPULATION AGAINST A SHARP SURFACE, SUCH AS THE METAL ENTRY NEEDLE THAT WAS USED DURING THE PROCEDURE. THE DEVICE LABELING STATES IN THE WARNINGS/PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS MAY RESULT IN DAMAGE OR SEPARATION OF THE POLYURETHANE COATING. FOR EXAMPLE, "DO NOT MANIPULATE/WITHDRAW THE GLIDEWIRE THROUGH A METAL NEEDLE/METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL NEEDLE/METAL DILATOR 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 INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PART OF THE GUIDEWIRE'S DISTAL TIP BECAME DETACHED DURING A CORONARY CATHETERIZATION PROCEDURE. REPORTEDLY, THE CARDIOLOGIST USED A PERCUTANEOUS NEEDLE TO GAIN ACCESS TO THE RIGHT FEMORAL ARTERY, AND THEN, PUT THE GLIDEWIRE THROUGH THE NEEDLE, WHICH SHEARED OFF THE TIP OF THE GUIDEWIRE. FLUOROSCOPY CONFIRMED THAT A "LITTLE BIT OF [THE GUIDE] WIRE [WAS] LEFT BEING [IN THE PATIENT]." THE PHYSICIAN EXPLAINED THE SITUATION TO THE PATIENT AND CONSULTATION WAS OBTAINED FROM A VASCULAR SURGEON. BASED ON THE AVAILABLE INFORMATION, THE PATIENT DECIDED NOT TO PURSUE ATTEMPTS AT REMOVAL OF THE DETACHED PIECE OF THE GUIDEWIRE. ACCESS WAS ACHIEVED THROUGH THE LEFT FEMORAL ARTERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FOLLOW-UP COMMUNICATION CONFIRMED THAT THE PATIENT HAS BEEN DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 070308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other METAL INTRODUCER NEEDLE