BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUTER TIP DEFLECTING WIRE GUIDE

    MDR report key: 7040983 · Received November 17, 2017

    Report

    Report Number
    1820334-2017-03904
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    November 6, 2017
    Report Date
    February 22, 2018
    Manufacturer
    COOK INC
    Product Code
    DXQ
    UDI-DI
    00827002007635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: PRODUCT CODE: DQX. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED REUTER TIP DEFLECTING WIRE GUIDE WAS RETURNED FOR INVESTIGATION. THE WIRE GUIDE HANDLE DOES NOT ACTIVATE THE DISTAL END OF WIRE GUIDE. THE PROXIMAL PORTION OF THE HANDLE IS SEPARATED FROM THE DISTAL PORTION OF THE HANDLE. THE CONNECTION CAP WAS NOT RETURNED. THE WIRE IS PARTIALLY SEPARATED AT THE DISTAL END OF THE HANDLE. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT AND SUBASSEMBLY DEVICE HISTORY RECORDS, SHOW NO NONCONFORMING EVENTS. IN ADDITION, THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE WIRE WAS PARTIALLY SEPARATED WHICH COULD BE A RESULT OF EXCESSIVE FORCE. PER THE IFU, "DO NOT USE EXCESSIVE FORCE WHEN DEFLECTING A REUTER TIP DEFLECTING WIRE GUIDE. EXCESSIVE USE OF FORCE CAN RESULT IN DAMAGE TO THE WIRE GUIDE." BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    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 THEINVESTIGATION.

    Description of Event or Problem · 1

    THE TDW-25-100-5 WAS ADVANCED FROM THE RADIAL ARTERY DURING THE PROCEDURE. THE METALLIC PART OF THE THE PROXIMAL END OF THE WIRE GUIDE SEPARATED FROM THE DEFLECTOR HANDLE WHILE BEING USED AND THE WIRE GUIDE BECAME IMPOSSIBLE TO MANIPULATE.ANOTHER MANUFACTURER'S WIRE GUIDE WAS USED INSTEAD WITHOUT PROBLEMS. NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821137 REUTER TIP DEFLECTING WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC G00763 00827002007635

    Patients

    Seq Age Sex Outcome Treatment
    1