BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1960214 · Received December 21, 2010

    Report

    Report Number
    9681834-2010-00037
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BASED UPON EVALUATION OF USER FACILITY INFORMATION AND PICTURES OF THE INVOLVED SAMPLE. BASED UPON EVALUATION OF RESERVE SAMPLE. CONCLUSIONS: BASED UPON EVALUATION OF USER FACILITY INFORMATION AND PICTURES OF THE INVOLVED SAMPLE. BASED UPON EVALUATION OF RESERVE SAMPLE. THE INVOLVED DEVICE IS IN TRANSIT TO THE MANUFACTURING FACILITY FOR EVALUATION. HOWEVER, PHOTOGRAPHS OF THE DEVICE HAVE BEEN EXAMINED. VISUAL INSPECTION OF THE PHOTOGRAPHS OF THE INVOLVED DEVICE CONFIRMED THAT THERE WAS DAMAGE TO THE POLYURETHANE COATING. A PORTION OF THE COATING WAS PARTIALLY SHEARED AND ROLLED BACK ON ITSELF. NO OTHER SIGNIFICANT INFORMATION COULD BE OBTAINED FROM THE EXAMINATION OF THE PICTURES. EVALUATION OF A RESERVE SAMPLE FROM THE REPORTED LOT CONFIRMED THERE WERE NO DEFECTS OR ABNORMALITIES. 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. THE EVENT DESCRIPTION AND PHOTOGRAPHS OF THE DEVICE ARE CONSISTENT WITH DAMAGE TO THE GUIDEWIRE COATING DUE TO MANIPULATION AGAINST A HARD, SHARP SURFACE DURING THE PROCEDURE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATING THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS "MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL." IN ADDITION, THE IFU STATES, "WHEN USING A DRUG OR DEVICE CONCURRENTLY WITH 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE INVOLVED SAMPLE IS RECEIVED AND EVALUATED AT THE MANUFACTURING FACILITY. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PORTION OF THE OUTER LAYER OF THE GUIDEWIRE HAD "ACCORDIONED" DURING A PROCEDURE. INFORMATION RECEIVED INCLUDED THE FOLLOWING: THE PHYSICIAN STATED THAT AFTER PASSING THE WIRE UP AND OVER THE ILIAC ARCH DOWN INTO THE CONTRA-LATERAL LOWER EXTREMITY, THE WIRE COATING "ACCORDIONED" AND HE COULD NOT "PASS THE CATHETER OVER IT;" THIS GUIDEWIRE WAS REMOVED AND A SECOND GLIDEWIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE; AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 090624

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATHETER