BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1982280 · Received February 1, 2011

    Report

    Report Number
    9681834-2011-00001
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    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 PT'S BODY. RESULTS - BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE & RETAINED SAMPLE. CONCLUSIONS - BASED UPON EVALUATION OF USER FACILITY INFORMATION & RETURNED SAMPLE; IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE & RETAINED SAMPLE. EVALUATION OF THE RETURNED SAMPLE BY THE MANUFACTURING FACILITY CONFIRMED THAT THE POLYURETHANE COATING HAD BEEN DAMAGED, SHEARED AND ROLLED BACK EXPOSING THE CORE WIRE. EXAMINATION & TESTING OF UNDAMAGED AREAS ON THE RETURNED SAMPLE & OF A RETAINED SAMPLE FOUND NO EVIDENCE OF AN ANOMALY OR DEFECT & PERFORMANCE SPECIFICATIONS WERE MET. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION AND THE APPEARANCE OF THE RETURNED SAMPLE ARE CONSISTENT WITH DAMAGE TO THE GUIDEWIRE DUE TO MANIPULATION AGAINST A METALLIC OBJECT (SUCH AS THE CYSTOSCOPE/URETEROSCOPE) DURING THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INSTRUCTIONS-FOR-USE DO ADDRESS THE POTENTIAL FOR SUCH AN EVENT BY STATING IN THE WARNINGS/PRECAUTIONS SECTION THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS (E.G. IN CONJUNCTION WITH DEVICES WHICH CONTAIN METAL PARTS) "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. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PORTION OF THE GUIDEWIRE WAS SHEARED DURING A CYSTOSCOPY-URETEROSCOPY PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: AFTER ADVANCING THE WIRE INTO THE URETER, IT WAS NOTED THAT A SECTION OF THE COATING "HAD COME OFF"; THE PHYSICIAN ATTEMPTED TO FLUSH THE COATING OUT OF THE URETER, BUT WAS UNSUCCESSFUL; THE SHEARED COATING WAS LEFT UNRETRIEVED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PT'S CONDITION IS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CORP, ASHITAKA NA 100729

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other CYSTOSCOPE/URETEROSCOPE