BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR GUIDING SHEATH

    MDR report key: 6290355 · Received January 31, 2017

    Report

    Report Number
    1820334-2017-00259
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    March 16, 2016
    Report Date
    March 16, 2016
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DYB
    UDI-DI
    00827002099944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW OF THE REPORT THAT WAS INITIATED DURING AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT THIS REPORT SHOULD HAVE BEEN SUBMITTED AS A MALFUNCTION REPORT. IN THIS CASE, NO PATIENT INJURY OCCURRED; HOWEVER, THIS MAY BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF IT RECURRED. (B)(4). THE REPORTED DEVICE RETURNED FOR EVALUATION. VISUAL INSPECTION NOTES THE HUB WAS DETACHED FROM THE SHEATH. A GO-NO-GO GAUGE DIMENSIONAL TEST WAS PERFORMED, WHICH CONFIRMED THAT THE SIZE OF THE FLARE MET SPECIFICATION. BASED ON A VISUAL INSPECTION OF THE SHEATH, THE FLARE APPEARED TO BE DISTORTED, WHICH IS INDICATIVE OF DAMAGE CAUSED BY THE FLARE BEING PULLED THROUGH THE CAP. IT IS FEASIBLE TO SUGGEST THAT THE REPORTED SEPARATION WAS CAUSED BY THE DEVICE MEETING RESISTANCE BEYOND ITS INTENDED DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRODUCER BECOME LOOSE FROM THE VALVE. PER ADDITIONAL INFORMATION, THE INTRODUCER DETACHED FROM THE VALVE. NO FRAGMENTS REMAINED WITHIN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72880 FLEXOR GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK VASCULAR INC N/A 00827002099944

    Patients

    Seq Age Sex Outcome Treatment
    1