BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE SPARTACORE GUIDE WIRE

    MDR report key: 2823142 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07036
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    August 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K980119
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY; HOWEVER, SOMETIME DURING THE PROCEDURE, THE SPARTACORE GUIDE WIRE TIP, APPROXIMATELY 3.5 CENTIMETERS, SEPARATED INSIDE THE PATIENT AND WAS RETRIEVED SUCCESSFULLY WITH A SNARE DEVICE. PATIENT IS REPORTED TO BE WELL. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention