BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 6747044 · Received July 27, 2017

    Report

    Report Number
    1820334-2017-02040
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 12, 2017
    Report Date
    October 23, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002299825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, 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 SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A FLEXOR ANSEL GUIDING SHEATH WAS BEING USED WITH A LYSIS CATHETER FOR A LYSIS PROCEDURE. IT WAS REPORTED THAT THE ONCE THE LYSIS CATHETER WAS PLACED IN THE ANSEL SHEATH IT APPEARED TO BE "LEAKING MORE THAN USUAL." THE ANSEL WAS REPLACED WITH A "55 RAABE," AND THEY PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526399 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC N/A 00827002299825

    Patients

    Seq Age Sex Outcome Treatment
    1