BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE

    MDR report key: 7132734 · Received December 19, 2017

    Report

    Report Number
    1820334-2017-04302
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 24, 2017
    Report Date
    April 17, 2018
    Manufacturer
    COOK INC
    Product Code
    DXQ
    UDI-DI
    00827002116740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE SAFETY WIRE WAS PROTRUDING 2.5 CM, AT A DISTANCE OF 3.7 CM FROM THE DISTAL TIP. THE DISTAL WELD WAS PRESENT, BUT ONLY ATTACHED TO THE COIL. THE PROXIMAL WELD WAS SECURE. THE SAFETY WIRE AND THE CORE WIRE WERE NOT SECURE AT THE DISTAL END. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED PRIOR TO USE, THE CORE WIRE BECAME PROTRUDED FROM THE WIRE GUIDE DURING THE SHAPING OF THE WIRE GUIDE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907186 AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC 00827002116740

    Patients

    Seq Age Sex Outcome Treatment
    1