BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCF 4FR 65CM CATHETER

    MDR report key: 4707071 · Received April 14, 2015

    Report

    Report Number
    MW5042140
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 14, 2015
    Manufacturer
    COOK MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED FOR A CORONARY AND PERIPHERAL DIAGNOSTIC CATH PROCEDURES. AFTER THE COMPLETION OF THE CORONARY PROCEDURE, EXCHANGE OF CATHETERS WERE DONE TO A 4 FR DIAGNOSTICS PERIPHERAL COOK VCF 65CM CATHETER, (B)(4), LOT #4527400 FOR THE PERIPHERAL SECTION OF THE CASE. IT WAS NOTED THAT THE TIP OF THIS CATHETER BROKE OFF AND NEEDED TO BE REMOVED. AN AMPLATZ GOOSE NECK SNARE ADVANCE 4 FR 102CM LOT #9842277 (B)(4) AND THEN AMPLATZ GOOSE NECK SNARE 10MM X 120CM WERE USED TO SUCCESSFULLY REMOVE THE VCF TIP. THE PT REMAINED IN STABLE CONDITION POST PROCEDURE AND WAS TRANSFERRED TO THE CATH RECOVERY AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249100 VCF 4FR 65CM CATHETER 4FR 65CM CATHETER DYB COOK MEDICAL G12394 4527400

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention