MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062943

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Aneurysm (1708); Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The disposition of the device involved in the event was unknown.It was not returned; therefore, a return sample evaluation is unable to be performed.A gastrointestinal ulcer is a known complication of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2020, the patient visited a hospital due to diarrhea and hematemesis.Marked anemia was noted, and hemorrhage of the digestive tract was suspected.On (b)(6) 2020, the patient had an endoscopy, but the j-tube blocked the view, so a diagnosis could not be made.On (b)(6) 2020, the patient visited a hospital again due to anemia, pyrexia, diarrhea and vomiting.On (b)(6) 2020, a hemoglobin level was drawn, with a result of 5g/dl.On (b)(6) 2020, a gastroscopy was performed, which showed an ulcer on the mucosa which was pressed by the j-tube the from stomach to the duodenum.During the gastroscopy, an attempt was made to remove the j-tube, but a knot was observed at the end of the tubing, so it could not be removed from the peg tube.During the procedure, an aneurysm and hemorrhage from the region were noted.The patient underwent coil embolization and remained hospitalized.The patient then became unconscious due to shock from decreased blood pressure.It was suspected that another region was hemorrhaging, so the physician performed another endoscopy.A second aneurysm was discovered, and the patient was treated with another coil embolization, then received a blood transfusion of 6000 cc and placed on a ventilator.On an unknown date, the j-tube was removed, and it was suspected that there might be a bezoar at the end of the tube, but it was not confirmed.Regarding massive hematemesis, the physician considered that the cause was a rupture of aneurysms which were pre-existing disease.The physician suspected that the ulcer was caused by the j-tube pulling distally and that the pulling of the tube also led to rupture of the aneurysms.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 9830749
• MDR Text Key: 186696783
• Report Number: 3010757606-2020-00182
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/27/2020

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: Lay User/Patient
• Device Catalogue Number: 062943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR