BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 FR 45CM FLEXOR CHECK-FLO INTRODUCER

    MDR report key: 2234377 · Received August 30, 2011

    Report

    Report Number
    MW5021970
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    COOK
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RETAINED FOREIGN BODY (6 FRENCH ANSEL SHEATH), RIGHT EXTERNAL ILIAC. WHEN ANSEL SHEATH WAS BEING REMOVED, IT DISENGAGED (BROKE OFF INSIDE BODY). CONNECTING BRAIDED WIRE RIBBON BETWEEN THE DISTAL TIP OF THE ANSEL SHEATH (WHICH REMAINED INSIDE BODY) WAS EXTERNALIZED. THIS WIRE RIBBON WAS SNIPPED (EXTERNALLY). STERILE DRESSING WAS PLACED OVER SITE AND PT PROCEEDED TO O.R. FOR EMERGENT CUT DOWN OF COMMON FEMORAL ARTERY TO REMOVE RETAINED SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 FR 45CM FLEXOR CHECK-FLO INTRODUCER ANSEL SHEATH DYB COOK KCFW-6.0-18/38-45-RB-ANL1-HC 2750043

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R