BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATHETER, FOLEY

    MDR report key: 6836308 · Received August 31, 2017

    Report

    Report Number
    6836308
    Event Type
    Death
    Date Received
    August 31, 2017
    Date of Event
    July 5, 2017
    Report Date
    August 29, 2017
    Manufacturer
    UNK
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A YOUNG ADULT PATIENT WITH A NEUROLOGICAL DISORDER PRESENTED TO A HOSPITAL EMERGENCY DEPARTMENT FROM A LONG TERM CARE FACILITY WITH A DISLODGED GASTROJEJUNOSTOMY (GJ) TUBE. THE OUTSIDE FACILITY HAD PLACED AN 18 FRENCH FOLEY CATHETER INTO THE OSTOMY AND INFLATED THE FOLEY BULB TO MAINTAIN PATENCY OF THE TRACK. THE DISTAL PORTION OF THE FOLEY CATHETER WAS TIED IN A LOOSE KNOT BUT NOT OTHERWISE SECURED. THE EXTERNAL PORTION OF THE FOLEY WAS VISIBLE AT THE TIME OF CONSULTATION BUT WHEN PATIENT WAS TAKEN TO RADIOLOGY FOR PLACEMENT OF THE GJ TUBE, THE FOLEY WAS NO LONGER PRESENT AND THOUGHT TO HAVE FALLEN OUT. THE NEW GJ TUBE(22 FRENCH) WAS PLACED WITHOUT RESISTANCE OR COMPLICATION, PLACEMENT VERIFIED WITH CONTRAST, AND USED FOR FEEDING. THE PATIENT DEVELOPED FEVER AND INCREASING ABDOMINAL DISTENTION. X-RAY SUGGESTIVE OF A PARTIAL OBSTRUCTION. SURGICAL CONSULT RECOMMENDED AGGRESSIVE NON SURGICAL INTERVENTIONS. ABDOMINAL CT IDENTIFIED ONLY A SMALL SEGMENT OF TUBING THOUGHT TO BE A FRAGMENT OF THE ORIGINAL DISLODGE G TUBE. PATIENT CONTINUED TO DETERIORATE IN SPITE OF VOLUME RESUSCITATION, ANTIBIOTICS, AND ATTEMPTS TO REDUCE THE OBSTRUCTION MEDICALLY. HE ARRESTED AND EXPIRED. ON AUTOPSY, THE ENTIRE FOLEY CATHETER WITH INFLATED BALLOON AND DISTAL KNOT WAS FOUND TO BE OBSTRUCTING THE SMALL BOWEL. THE FOLEY CATHETER APPEARS TO HAVE BEEN PULLED INTO THE BOWEL BY PERISTALSIS. THE TUBE WAS NOT READILY VISIBLE ON IMAGING. THE SMALL "SEGMENT" IDENTIFIED ON CT WAS LIKELY ONLY A DISTAL PORT VALVE OF THE FOLEY.

    Description of Event or Problem · 1

    A YOUNG ADULT PATIENT WITH A NEUROLOGICAL DISORDER PRESENTED TO A HOSPITAL EMERGENCY DEPARTMENT FROM AN LONG TERM CARE FACILITY WITH A DISLODGED GASTROJEJUNOSTOMY (GJ) TUBE. THE OUTSIDE FACILITY HAD PLACED AN 18 FRENCH FOLEY CATHETER INTO THE OSTOMY AND INFLATED THE FOLEY BULB TO MAINTAIN PATENCY OF THE TRACK. THE DISTAL PORTION OF THE FOLEY CATHETER WAS TIED IN A LOOSE KNOT BUT NOT OTHERWISE SECURED. THE EXTERNAL PORTION OF THE FOLEY WAS VISIBLE AT THE TIME OF CONSULTATION BUT WHEN PATIENT WAS TAKEN TO RADIOLOGY FOR PLACEMENT OF THE GJ TUBE, THE FOLEY WAS NO LONGER PRESENT AND THOUGHT TO HAVE FALLEN OUT. THE NEW GJ TUBE(22 FRENCH) WAS PLACED WITHOUT RESISTANCE OR COMPLICATION, PLACEMENT VERIFIED WITH CONTRAST, AND USED FOR FEEDING. THE PATIENT DEVELOPED FEVER AND INCREASING ABDOMINAL DISTENTION. X-RAY SUGGESTIVE OF A PARTIAL OBSTRUCTION. SURGICAL CONSULT RECOMMENDED AGGRESSIVE NON SURGICAL INTERVENTIONS. ABDOMINAL CT IDENTIFIED ONLY A SMALL SEGMENT OF TUBING THOUGHT TO BE A FRAGMENT OF THE ORIGINAL DISLODGE G TUBE. PATIENT CONTINUED TO DETERIORATE IN SPITE OF VOLUME RESUSCITATION, ANTIBIOTICS, AND ATTEMPTS TO REDUCE THE OBSTRUCTION MEDICALLY. HE ARRESTED AND EXPIRED. ON AUTOPSY, THE ENTIRE FOLEY CATHETER WITH INFLATED BALLOON AND DISTAL KNOT WAS FOUND TO BE OBSTRUCTING THE SMALL BOWEL. THE FOLEY CATHETER APPEARS TO HAVE BEEN PULLED INTO THE BOWEL BY PERISTALSIS. THE TUBE WAS NOT READILY VISIBLE ON IMAGING. THE SMALL "SEGMENT" IDENTIFIED ON CT WAS LIKELY ONLY A DISTAL PORT VALVE OF THE FOLEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616630 CATHETER, FOLEY EZL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death