BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI STICK 4.0 F X 10CM STIFF INTRODUCER

    MDR report key: 7758923 · Received August 7, 2018

    Report

    Report Number
    1722746-2018-00011
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 8, 2018
    Manufacturer
    MEDRON, LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDORN IS A CONTRACT MANUFACTURER AND DOES NOT OWN THE DESIGN OF THE DEVICE AND DOES NOT SELL THE DEVICE TO END USERS. WHEN A FAILURE OCCURS, MEDRON ASSESSES THE DEVICE HISTORY RECORD AND THE PHYSICAL SAMPLE (WHEN AVAILABLE). (B)(4).

    Description of Event or Problem · 1

    MEDRON WAS NOTIFIED BY ANGIO DYNAMICS THAT "WE RECEIVED A CUSTOMER COMPLAINT STATING THAT "ON (B)(6) 2018, A (B)(6) FEMALE WITH AN EXTENSIVE VASCULAR HISTORY UNDERWENT AN ATTEMPTED CATHETERIZATION USING A MINI STICK MAX VIA LEFT FEMORAL ACCESS. AS THE INTERVENTIONALIST ATTEMPTED TO PULL OUT THE MICROPUNCTURE SHEATH, THE PROXIMAL PORTION SNAPPED OFF LEAVING THE MAJORITY OF THE SHEATH IN SITU. THE RETAINED SHEATH COULD NOT BE VISUALIZED (NOT RADIOPAQUE UNDER FLUOROSCOPY.) THE PATIENT WAS TAKEN TO THE OR FOR A SURGICAL CUTDOWN, PLACEMENT OF A BOVINE PATCH AND SHEATH REMOVAL. WE ARE RETURNING ONE 4F INTRODUCER FOR EVALUATION. THE 4F INTRODUCER HAS BEEN DISINFECTED USING A 1:10 BLEACH AND WATER MIXTURE AND PLACED IN OUR OVEN FOR 1 HOUR TO DRY BUT SHOULD BE CONSIDERED BIO-HAZARD MATERIALS. PEASE PERFORM AN EVALUATION OF THE RETURNED SAMPLE, A DHR REVIEW FOR THE NOTED LOT {170269}."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601341 MINI STICK 4.0 F X 10CM STIFF INTRODUCER DYB MEDRON, LLC 1331-002 170269

    Patients

    Seq Age Sex Outcome Treatment
    1