MAUDE Adverse Event Report:; CATHETER, FOLEY

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Death (1802); Fever (1858); Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Date 07/05/2017

Event Type  Death  

Event Description

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.

Event Description

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.

• Type of Device: CATHETER, FOLEY
• MDR Report Key: 6836308
• MDR Text Key: 84997110
• Report Number: 6836308
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 26 YR
• Patient Weight: 59