BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 6729794 · Received July 20, 2017

    Report

    Report Number
    1820334-2017-01799
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 26, 2017
    Report Date
    October 18, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002299962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, UNUSED PRODUCT, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, INSTRUCTIONS FOR USE (IFU), AND DEVICE HISTORY RECORD 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. A REPRESENTATIVE FLEXOR ANSEL GUIDING SHEATH SET FROM LOT# 7232092 WAS OBTAINED FOR EXAMINATION. THE .038 INCH DILATOR WAS INSERTED INTO THE SHEATH WITH NO RESISTANCE. SMOOTH TRANSITION WAS NOTED BETWEEN THE DILATOR AND SHEATH. NO NON-CONFORMITIES WERE NOTED WITH THE SHEATH, THE .038 INCH DILATOR OR THE .018 INCH DILATOR. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER IT IS LIKELY THAT CALCIFICATION PRESENT IN THE PATIENT'S ANATOMY COULD HAVE LED TO THE DILATOR TIP FRAYING. THE PHYSICIAN STATED, "I FELT THAT THE DEVICE WAS CAUGHT ON CALCIFICATION." 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 THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER INSERTION OF THE 4FR SHORT SHEATH, THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT (CONTRALATERAL APPROACH). HOWEVER, IT COULD NOT BE INSERTED INTO THE VESSEL RESULTING IN DAMAGE (FRAY) IN THE DILATOR TIP. AS A RESULT, THE SHEATH WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510032 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC 00827002299962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other