BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 2063307 · Received April 13, 2011

    Report

    Report Number
    9681834-2011-00015
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: IS BASED UPON EVAL OF USER FACILITY INFO AND RETURNED SAMPLE; IS BASED UPON EVAL OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. CONCLUSIONS: IS BASED UPON EVAL OF USER FACILITY INFO AND RETURNED SAMPLE; IS BASED UPON EVAL OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE INVOLVED DEVICE WAS RETURNED AND EVALUATED BY QA AT THE MFG FACILITY. EXAMINATION CONFIRMED: THE URETHANE COATING HAD BEEN PEELED AWAY FROM THE CORE WIRE STARTING APPROX 250-MM FROM THE DISTAL END; THE COATING WAS THEN ROLLED BACK ON ITSELF IN THE DISTAL DIRECTION EXPOSING APPROX 8-MM OF CORE WIRE AND MEASUREMENT CONFIRMED NONE OF THE URETHANE COATING HAD COMPLETELY DETACHED. INSPECTION AND TESTING OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE CONFIRMED THAT THERE WERE NO PRE-EXISTING DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFO. THE RESULTS OF THE EVAL OF THE RETURNED SAMPLE ARE MOST CONSISTENT WITH DAMAGE TO THE GUIDEWIRE COATING DUE TO THE DISTAL EDGE OF ANOTHER DEVICE PUSHING BACK THE PROXIMAL END OF THE URETHANE COATING SUCH THAT IT WAS PARTIALLY PEELED OFF THE WIRE AND THEN ROLLED BACK ON ITSELF IN THE DISTAL DIRECTION DURING REMOVAL. 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 "SHEARING OF THE GLIDEWIRE ADVANTAGE, 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 ADVANCE, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE GLIDEWIRE ADVANTAGE." ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QA AT THE MFG FACILITY FOR APPROPRIATE TRACKING, TRENDING AND F/U. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PORTION OF THE GUIDEWIRE COATING HAD BEEN DISPLACED DURING A PROCEDURE EXPOSING, THE CORE WIRE. F/U COMMUNICATION CONFIRMED: RESISTANCE WAS ENCOUNTERED DURING ADVANCING OF THE GUIDEWIRE; THE ENTIRE DEVICE WAS ABLE TO BE REMOVED; THE GLIDEWIRE COATING WAS DESCRIBED AS "PROTRUDING" AT THE DISTAL END OF THE DEVICE AND THERE WAS NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE ADVANTAGE DQX TERUMO CORPORATION, ASHITAKA NA 101202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT| 5FR. CORDIS TEMPO CATHETER| 4FR. CORDIS MP CATHETER| 7FR. PTA BALLOON| CORDIS 7FR. POWER FLEX PTA BALLOON