BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECURVED PALINDROME EMERALD 19/36KIT

    MDR report key: 2031915 · Received March 22, 2011

    Report

    Report Number
    1317749-2011-00103
    Event Type
    Other
    Date Received
    March 22, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 18, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/22/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 03/18/2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THAT AFTER INSERTION OF LINE (RIGHT IJ) OVER THE GUIDEWIRE (VENATRAC), REMOVAL OF THE GUIDEWIRE WAS NOT POSSIBLE. THE DISTAL TIP (J-TIP) OF THE GUIDEWIRE BECAME LODGED IN THE DISTAL VENATRAC STIFFENER AND IT WAS NOT ABLE TO BE PULLED OUT. THE PROXIMAL VENATRAC STIFFENER WAS REMOVED LEAVING THE GUIDEWIRE IN PLACE. THE DISTAL STIFFENER WAS THEN REMOVED AND WITH IT CAME 1 CM OF THE GUIDEWIRE (J-TIP). THE REMAINING GUIDEWIRE UNRAVELED WITH FURTHER ATTEMPTS TO REMOVE IT AND FINALLY BROKE OFF. TEN CM (APPROX) OF GUIDEWIRE REMAINED IN THE PT AND THIS SUBSEQUENTLY LODGED IN THE PROXIMAL TRUNK OF THE R PULMONARY ARTERY. THE PT REQUIRED URGENT REMOVAL OF FOREIGN BODY BY AN INTERVENTIONAL RADIOLOGIST. THIS WAS PERFORMED SUCCESSFULLY THROUGH THE RIGHT FEMORAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECURVED PALINDROME EMERALD 19/36KIT HEMODIALYSIS CATHETER MSD COVIDIEN 8888145068 809402

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention