BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE M

    MDR report key: 4192174 · Received October 22, 2014

    Report

    Report Number
    9681834-2014-00260
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 22, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION REVEALED THAT THE URETHANE LAYER HAD BEEN SHEARED OFF THE GUIDEWIRE AT APPROXIMATELY 84-195MM FROM THE DISTAL END. MAGNIFYING INSPECTION OF THE SHEARED SEGMENT FOUND THAT THE SHEAR CROSS-SECTION HAD A SMOOTH SURFACE AND THE DISTAL END HAD BECOME ROUGH. THIS SUGGESTS THAT THE URETHANE LAYER WAS SHEARED OFF IN THE DISTAL DIRECTION FROM THE PROXIMAL. IT IS LIKELY THAT THE SHEARING OCCURRED WHEN THE ACTUAL SAMPLE WAS WITHDRAWN THROUGH THE INVOLVED METAL NEEDLE. TACTILE TESTING WAS PERFORMED BY PRIMING THE UNDAMAGED SEGMENTS OF THE ACTUAL SAMPLE WITH SALINE SOLUTION AND FEELING FOR ANY CATCHES. NONE WERE FELT. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET PRODUCT SPECIFICATIONS AND COMPARABLE TO CURRENT PRODUCT. FURTHER TESTING OF THE GUIDEWIRE INVOLVED INTENTIONALLY SHEARING THE URETHANE LAYER FROM THE REMAINING UNDAMAGED SEGMENT TO CHECK ADHESION. NO ANOMALIES WERE REVEALED. BASED ON INVESTIGATION FINDINGS, THERE IS NO INDICATION THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE FINDINGS SUGGEST THAT THE URETHANE LAYER WAS SHEARED OFF THE WIRE WHEN THE ACTUAL SAMPLE WAS WITHDRAWN THROUGH THE CONCOMITANT METAL NEEDLE. DEVICE LABELING ADDRESSES THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE WARNING SECTION FOUND IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS, "DO NOT MANIPULATE/WITHDRAW THE GUIDEWIRE M THROUGH A METAL ENTRY NEEDLE, A METAL DILATOR OR A METAL GUIDE WIRE INSERTER. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE, A METAL DILATOR OR A METAL GUIDE WIRE INSERTER MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A RADIFOCUS GUIDEWIRE M WAS USED DURING A PROCEDURE CONCOMITANTLY WITH A MRI PORT AND ITS METAL NEEDLE. THERE WAS A STRONG RESISTANCE AND "CATCH" FEELING WHEN THE DEVICE WAS WITHDRAWN. THE URETHANE LAYER HAD SHEARED BUT WAS COMPLETELY RETRIEVED OUTSIDE THE PATIENT'S BODY. REPORTEDLY THERE WAS NO HARM TO THE PATIENT. THE SHEARED URETHANE LAYER OCCURRED ON TWO (2) OF THE SAME PRODUCTS IN SUCCESSION. THE OTHER EVENT IS REPORTED IN MDR NUMBER 9681834-2014-00264.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671283 RADIFOCUS GLIDEWIRE M GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 MRI PORT ASSOCIATED METAL NEEDLE| MRI PORT (MEDICON INC)