BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW WEDGE PRESSURE CATHETER

    MDR report key: 3962743 · Received July 17, 2014

    Report

    Report Number
    3962743
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 3, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ARROW INTERNATIONAL, INC.(SUBSIDIARY OF TELEFLEX, INC.)
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A 4FR ARROW WEDGE CATH WAS OPENED AND FOUND TO BE DEFECTIVE; THE BALLOON WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417850 ARROW WEDGE PRESSURE CATHETER CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL, INC.(SUBSIDIARY OF TELEFLEX, INC.) 4FR 16F14A0007

    Patients

    Seq Age Sex Outcome Treatment
    1 * OUT-OF-PACKAGE FAILURE.| PATIENT INFORMATION WAS NOT RECORDED FOR THIS