BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DIALYSIS

    MDR report key: 3212765 · Received July 2, 2013

    Report

    Report Number
    1317749-2013-00184
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 10, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES A FEMALE PT WAS ADMITTED FOR A GI BLEED AND ACUTE RENAL FAILURE. REQUIRED A DIALYSIS CATHETER FOR IMPENDING DIALYSIS. ON (B)(6) 2013 AT APPROX 1100 A MAHURKAR Q PLUS DUAL LUMEN CATHETER KIT WITH CURVED EXTENSIONS WAS USED FOR DIALYSIS ACCESS. CHEST X-RAY POST PLACEMENT CONFIRMED THAT THE CATHETER TIP WAS IN THE RIGHT ATRIUM. IT NEEDED TO BE PULLED BACK APPROX 6 CM. IT APPROX 1600 THE CATHETER WAS BEING EXCHANGED FOR A 16 CM CATHETER. THE GUIDE WIRE WAS RE-THREADED AND THE PT COMPLAINED OF SHORTNESS OF BREATH. ANOTHER X-RAY WAS TAKEN AND THIS PLACEMENT WAS INCORRECT AND RAISED CONCERN FOR PERFORATION. CHEST CT SCAN WAS PERFORMED AND CONFIRMED THE IJ CATHETER DISTAL TIP WITHIN THE LEFT UPPER ANTERIOR MEDIASTINUM OUTSIDE OF THE DEEP VEINS. SUSPECT PERFORATION OF THE BRACHIOCEPHALIC VEIN WITH DEPENDENT AIR AND SMALL HEMATOMA. UPON REMOVAL OF THE CATHETER AND GUIDE WIRE IT WAS DETERMINED THAT THE GUIDE WIRE HAD EXITED THE SIDE PORT OF THE CATHETER (ABNORMAL) AND POTENTIALLY CAUSED THE PERFORATION OF THE VESSEL. PT WAS TRANSFERRED TO MGH IN BOSTON FOR VASCULAR REPAIR. AS OF (B)(6) 2013 PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300515 UNKNOWN DIALYSIS DIALYSIS CATHETER MPB COVIDIEN UNKNOWN DIALYSIS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention