BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 3182659 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03865
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL 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 REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED BELOW THE KNEE ARTERY. A WHISPER GUIDE WIRE WAS BEING ADVANCED TO THE ARTERY; HOWEVER, IT COULD NOT ADVANCE THROUGH THE CALCIFICATION AND THE GUIDE WIRE WAS REMOVED. WHEN IT WAS OUTSIDE THE ANATOMY IT WAS NOTED THAT THE TIP HAD SEPARATED. THE GUIDE WIRE TIP COULD NOT BE SNARED DUE TO THE ANATOMY AND UNDER ANGIOGRAPHY IT WAS NOTED THAT THE TIP HAS MIGRATED ALL THE WAY DOWN THE LEG. A NON-ABBOTT GUIDE WIRE WAS ADVANCED THROUGH THE LESION TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282836 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 3030271

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other