BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORPHEUS 5 FRENCH DUAL LUMEN PICC LINE

    MDR report key: 664210 · Received December 8, 2005

    Report

    Report Number
    MW1037381
    Event Type
    Malfunction
    Date Received
    December 8, 2005
    Report Date
    December 8, 2005
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE WIRE THAT IS USED IN THE PROCESS OF PLACING THE CATHETER IN THE PT HAS BEEN GETTING STUCK INSIDE THE CATHETER. CAUSING THE DR TO ABORT THE PROCEDURE AND REMOVE THE CATHETER. NO PTS WERE HARMED BUT THE RISK OF A PROBLEM EXITS BECAUSE ANY FORCE TRYING TO REMOVE THE WIRE COULD RESULT IN THE WIRE FRACTURING AND THE WIRE MIGRATING INTO THE PULMONARY ARTERY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 02/23/06: PLEASE MAKE NOTE OF THE WARNING IN THE INSTRUCTIONS FOR USE, "NEVER USE FORCE TO REMOVE THE .018" GUIDEWIRE. RESISTANCE CAN DAMAGE THE CATHETER. IF RESISTANCE OF BUNCHING OF THE CATHETER IS OBSERVED, STOP GUIDEWIRE WITHDRAW AND ALLOW THE CATHETER TO RETURN TO NORMAL SHAPE. WITHDRAW BOTH THE CATHETER AND GUIDEWIRE TOGETHER APPROXIMATELY 2CM AND REATTEMPT GUIDEWIRE REMOVAL. REPEAT THIS PROCEDURE UNTIL THE GUIDEWIRE IS EASILY REMOVED. ONCE THE GUIDEWIRE IS OUT. ADVANCE THE CATHETER INTO THE DESIRED POSITION (ZERO MARK)." ANGIODYNAMICS RESEARCHED OUT COMPLAINT LOT TO VERIFY IF THE COMPLAINT MATCHED UP TO ONE THAT HAD BEEN REPORTED. HOWEVER, WITHOUT THE HOSPITAL NAME ANGIODYNAMICS WAS UNABLE TO MATCH UP A REPORTED COMPLAINT. THE CATALOG NUMBER AND LOT NUMBER DID MATCH WITH A REPORTED COMPLAINT. THE COMPLAINT WAS FOR THE MORPHEUS CT PICC IN WHICH THE GUIDEWIRE GOT STUCK IN THE CATHETER. DUE TO THE FACT THAT THE COMPLAINT DID NOT COMPLETELY MATCH UP WITH THE INFO PROVIDED IN THE VOLUNTARY FDA MEDWATCH REPORT, ANGIODYNAMICS HAS OPENED A COMPLAINT FILE WITH THE INFO PROVIDED. ALTHOUGH ANGIODYNAMICS HAS RECEIVED COMPLAINTS FOR THE GUIDEWIRE GETTING STUCK INSIDE THE CATHETER, WE HAVE NOT RECEIVED ANY REPORTS REFERENCING OR INDICATING THE POSSIBLE COMPLAINT TYPE HAD OR COULD OCCUR. ANGIODYNAMICS HAS FORWARDED THE COMPLAINTS FOR THE GUIDEWIRE GETTING STUCK INSIDE THE CATHETER TO A MEDICAL DIRECTOR FOR A RISK ANALYSIS. THE MEDICAL DIRECTOR HAS REPORTED, "THIS TYPE OF PRODUCT FAILURE WOULD NOT BE EXPECTED TO GIVE RISE TO SERIOUS HARM OR PERMANENT INJURY." ANGIODYNAMICS HAS BEEN MADE AWARE OF THE GUIDEWIRE GETTING STUCK IN THE CATHETER AND HAS OPENED CORRECTIVE ACTION TO ADDRESS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORPHEUS 5 FRENCH DUAL LUMEN PICC LINE PICC LINE LJS ANGIODYNAMICS 5FRENCH DUAL LUMEN 584392

    Patients

    Seq Age Sex Outcome Treatment
    1 *