BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PLUS PRESSURE GUIDE WIRE

    MDR report key: 8100316 · Received November 24, 2018

    Report

    Report Number
    2939520-2018-00183
    Event Type
    Malfunction
    Date Received
    November 24, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 28, 2018
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    UDI-DI
    00845225002879
    PMA / PMN Number
    K161887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE: 220785. THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. ENTRY ERROR COMPLAINT NARRATIVE. CHANGED FROM " THE IMAGE WAS LOST." TO, "THE SIGNAL WAS LOST ON THE MANUFACTURE'S DEVICE." UPDATED NAME AND PHONE NUMBER TO CURRENT SAFETY OFFICER. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT AN ENTRY ERROR IN THE COMPLAINT NARRATIVE FROM IMAGE WAS LOST TO THE SIGNAL WAS LOST.

    Additional Manufacturer Narrative · 1

    (B)(4). FACILITY DECLINED TO PROVIDE PATIENT INFORMATION. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE THE IMAGE WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND OF THE SAME MAKE AND MODEL. VISUAL, MICROSCOPIC INSPECTION, AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. A PORTION OF THE SENSOR WAS BROKEN AND MISSING. THE REPORTED FAILURE COULD NOT BE DUPLICATED, THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE PROBABLE CAUSE OF THE OBSERVED DAMAGE SENSOR COULD NOT BE CONCLUSIVELY DETERMINED BY THE INVESTIGATION. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE A PORTION OF THE SENSOR IS MISSING FROM THE DEVICE, IT COULD NOT CONCLUSIVELY BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939821 VERRATA PLUS PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 10185P 0301481187 00845225002879

    Patients

    Seq Age Sex Outcome Treatment
    1