BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR INTRODUCER SHEATH

    MDR report key: 3122529 · Received May 16, 2013

    Report

    Report Number
    1820334-2013-00188
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    April 15, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNK AS LOT NUMBER IS UNK. DEVICE: MATERIAL SEPARATION IS SPECIFICALLY LISTED IN THE INSTRUCTIONS FOR USE. NO PRODUCT HAS BEEN RETURNED; HOWEVER, THE CUSTOMER REPORTS THAT THE FITTING ASSEMBLY SEPARATED FROM THE SHEATH. THE INSTRUCTION FOR USE INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. CONFIRMATION BASED ON CUSTOMER'S STATEMENTS OF THE EVENT. DEVICES ARE 100% INSPECTED FOR FITTING SECURITY. WITHOUT BENEFIT OF INSPECTING THE COMPLAINT DEVICE, IT IS DIFFICULT TO DETERMINE WITH CERTAINTY WHY THE FAILURE MODE OCCURRED RESULTING IN MINOR HARM TO THE PT WHERE PHYSICIAN INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE SEGMENT. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS OCCURRENCE AND WE ARE CONTINUING OUR MONITORING OF COMPLAINTS FOR THIS FAILURE MODE. QUALITY ENGINEERING EVALUATED THE RISK TO PT FOR THIS PRODUCT FAMILY AND FAILURE MODE AND DETERMINED WITH THE ADDITION OF THIS EVENT, NO RISK REDUCTION ACTIVITIES ARE REQUIRED.

    Description of Event or Problem · 1

    A PT WITH EXTREME SCARRING UNDERWENT A PROCEDURE. A SHEATH WAS PLACED IN THE LEG AND UPON WITHDRAWING THE SHEATH, IT BROKE AT THE SIDE ARM HUB. A HEMOSTAT WAS USED TO PULL THE SHEATH BACK. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217694 FLEXOR INTRODUCER SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention