BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER/INTRODUCER COMBO SYSTEM

    MDR report key: 3790996 · Received May 5, 2014

    Report

    Report Number
    2015691-2014-01028
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 4, 2014
    Report Date
    April 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K001063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE OF THE HOSPITAL FOR ADDITIONAL INFORMATION REGARDING THE EVENT AND CONDITION OF THE PATIENT. PER HOSPITAL POLICY THE DEVICE WILL NOT BE RELEASED FOR EVALUATION. IF ADDITIONAL INFORMATION AND OR THE DEVICE HISTORY REVIEW BECOMES AVAILABLE A FOLLOW-UP SUBMISSION WILL BE SUBMITTED. THE HOSPITAL MEDWATCH NUMBER- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WOULD NOT DEFLATE. IT IS UNKNOWN IF THE INFLATION SYRINGE WAS REMOVED FROM THE GATE VALVE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268373 CATHETER/INTRODUCER COMBO SYSTEM CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR K9FC146F7 59465826

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR