BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1982266 · Received February 1, 2011

    Report

    Report Number
    9681834-2011-00002
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    TERUMO CORPORATION, ASHITIKA
    Product Code
    DQX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NON-RESORBABLE MATERIAL UNRETRIEVED IN THE BODY. METHOD: THE INVOLVED DEVICE WAS NOT RETAINED BY THE USER FACILITY FOR EVALUATION AND NEITHER THE PRODUCT CODE NOR LOT NUMBER IS KNOWN. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO A REVIEW OF USER FACILITY INFORMATION. AS NOTED ABOVE, DUE TO THE LACK OF THE IDENTITY OR RETURN OF THE INVOLVED DEVICE FOR EVALUATION, THE FAILURE INVESTIGATION WAS LIMITED TO A REVIEW OF USER FACILITY INFORMATION. THE REPORTED INFORMATION DOES NOT INDICATE THAT ANY DEFECT OR MALFUNCTION OF THE GUIDEWIRE DEVICE OCCURRED DURING USE. THIS MANUFACTURER MEDWATCH REPORT IS BEING SUBMITTED BECAUSE IT WAS THEORIZED THAT THE "ARTIFACT" REPORTEDLY OBSERVED ON THE FOLLOW-UP CT SCAN WAS EITHER A PORTION OF THE GUIDEWIRE OR A PIECE OF THE COATING FROM THE GUIDEWIRE. IN ADDITION, THE "ARTIFACT" REPORTEDLY OBSERVED ON THE FOLLOW-UP CT SCAN WAS UNABLE TO BE RETRIEVED FROM THE PT. WHILE THE CAUSE OF THE "ARTIFACT REPORTEDLY OBSERVED ON THE FOLLOW-UP CT SCAN CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, THE POTENTIAL THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS MAY RESULT IN DAMAGE OR SEPARATION OF THE POLYURETHANE COATING IS ADDRESSED IN THE DEVICE LABELING. SPECIFIC STATEMENTS IN THE WARNINGS/PRECAUTIONS SECTION INCLUDE: "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"; AND "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." IN ADDITION, THE LABEL ON THE POUCH CONTAINING EACH GLIDEWIRE HAS A PICTURE AND THE WORDS "DO NOT USE WITH METAL ENTRY NEEDLE." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A FOLLOW-UP CT SCAN REVEALED WHAT APPEARED TO BE FOREIGN MATERIAL IN A PT WHO HAD UNDERGONE A PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: DURING THE INITIAL PROCEDURE, AN EP CARDIOLOGIST PLACED A GLIDEWIRE INTO THE PT THROUGH A METAL ENTRY NEEDLE; NO COMPLICATIONS OR DEVICE PROBLEMS WERE NOTED DURING THAT INITIAL PROCEDURE; WHILE REVIEWING THE PT'S FOLLOW-UP CT SCAN, AN IMAGE DESCRIBED AS AN "ARTIFACT" WAS OBSERVED; AN INTERVENTIONAL RADIOLOGIST WAS CONSULTED AND THEY CONCURRED THAT THE "ARTIFACT" WAS EITHER A PORTION OF THE WIRE OR THE HYDROPHILIC COATING ON THE WIRE; THE PHYSICIAN ATTEMPTED TO RETRIEVE THE "ARTIFACT" BUT WAS UNSUCCESSFUL; THERE HAVE BEEN NO REPORTED PT COMPLICATIONS DURING OR SINCE THE PROCEDURES; AND THE PT HAS RECENTLY REQUESTED CLARIFICATION FROM THE HOSPITAL OF WHAT MAY HAVE BEEN LEFT INSIDE THEIR BODY DURING THE INITIAL PROCEDURE 6-MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CORPORATION, ASHITIKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other METAL ENTRY NEEDLE