BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE SPARTACORE GUIDE WIRE

    MDR report key: 2061308 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02703
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K980119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PRODUCT AND ITS PACKAGING WERE NOT RETURNED; THEREFORE, THE EXPIRATION DATE ON THE SPECIFIC PRODUCT LABELS COULD NOT BE CONFIRMED. HOWEVER, A REVIEW OF THE LABELS ATTACHED TO THE LOT HISTORY RECORD FOR THIS LOT WAS CONDUCTED AND ALL LABELS INDICATED AN EXPIRATION DATE OF (USE BY DATE) OF (B)(6) 2011. THIS CONFIRMS THAT THE PRODUCT WAS LABELED CORRECTLY AND BASED ON THE REPORTED INFORMATION, THE PRODUCT WAS USED 25 DAYS PAST THE LABELED EXPIRATION DATE. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR THE STERILITY, EFFICACY AND PERFORMANCE OF THE DEVICE. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTION FOR USE (IFU) STATES: REFER TO THE DEVICE LABEL FOR ANY ADDITIONAL PRODUCT SPECIFIC INDICATIONS THAT MAY APPLY. CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS. THIS INCLUDES THE PRODUCT EXPIRATION DATE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. IN THIS CASE, THE USE OF THE GUIDE WIRE AFTER THE EXPIRATION DATE IS USER RELATED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL ILIAC ARTERY ANGIOPLASTY AND STENTING PROCEDURE A SPARTACORE WIRE WAS ADVANCED. IT WAS NOTICED THAT THE PRODUCT HAD EXPIRED (FEB 2011). THE WIRE WAS REMOVED AND A GLIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE SPARTACORE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 9031291

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR