BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-J FIXED CORE WIRE GUIDE

    MDR report key: 6178393 · Received December 15, 2016

    Report

    Report Number
    1820334-2016-01477
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 13, 2016
    Report Date
    June 24, 2017
    Manufacturer
    COOK INC
    Product Code
    DXQ
    UDI-DI
    00827002005112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    (B)(4). "A J WIRE WAS USED DURING A CT GUIDED PANCREATIC DRAIN INSERTION ON SUNDAY ((B)(6) 2016). A SMALL FOREIGN BODY WAS NOTED IN THE COLLECTION WHEN REVIEWING THE SCANS THE FOLLOWING DAY. IT WAS NOT NOTICED THAT PART OF THE WIRE WAS MISSING AT ANY POINT IN THE PROCEDURE POST REMOVAL OF THE WIRE AND IT HAS BEEN NOTED THAT THE J SHAPE WAS STILL INTACT. UPON REVIEWING THE IMAGES THE ONLY PLAUSIBLE EXPLANATION AT THIS STAGE IS THAT THE DISTAL END OF THE J-WIRE SNAPPED WHILST THE DRAIN WAS BEING FORMED. IT IS UNLIKELY TO CAUSE ANY HARM AS IT¿S IN THE COLLECTION. A PLAN HAS BEEN DISCUSSED TO REMOVE IT SAFELY. THE J-WIRE REMOVED FROM THE PATIENT IS BELIEVED TO BE IN AN ALMOST FULL LARGE SHARPS BIN WHICH HAS BEEN SEALED AND LABELED." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828198 SAFE-T-J FIXED CORE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A 00827002005112

    Patients

    Seq Age Sex Outcome Treatment
    1