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 Death (1802); Necrosis (1971); Ulceration (2116)

Event Date 07/22/2019

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was discarded and was not returned; therefore, a return sample evaluation is unable to be performed.Catalog number is the international list number which is similar to us list number of 062918.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in the (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the peg-tail (intestinal tube / j tube) probe had caused the necrosis to develop in the intestinal mucosa where it came in contact with the intestine.A nurse stated that this was probably due to pressure of the probe on the mucous membrane.The j tube was removed and discarded.Multiple attempts to obtain further information was declined by the hospital.

Event Description

Additional information received on 04 oct 2019: on (b)(6) 2019, a patient in the netherlands underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.The on (b)(6) 2019, the patient was seen in the clinic due to persistent abdominal complaints since the tubing placement.The patient had no acute abdomen during the physical examination but had a high c-reactive protein (crp) level of 430, in which an unspecified antibiotic was started.A ct scan was done, which revealed a substantial amount of free air was seen with a non-fixed peg plate on the abdominal wall, distal part of the probe is curled on the scan in pars verticalis of the duodenum, normal spread after gift contrast over the peg-j in the duodenum, and no perforation was seen.After a few days of antibiotic use, a gastroscopy performed on (b)(6) 2019 revealed a large necrotic ulcer in the duodeni bulbus and the pigtail from the jejunum extension was in the bulbus.The extension was put back into the stomach with biopsy to give the ulcer the chance to heal in addition to treatment with high dose proton pump inhibitors.On (b)(6) 2019 during the evening, the patient experienced a sudden increase in pain complaints.A ct scan of the abdomen was performed on (b)(6) 2019 which revealed a substantial amount of free abdominal air and fluid (peritonitis image), no perforation visible.End of life care policy was chosen by the physician and a neurologist in consultation with the patient and her family.On (b)(6) 2019, the patient died in the hospital.At the time of report, the cause of death was reported as end of life care.It was unknown if an autopsy was performed.An alternative etiology of the event of necrosis in intestinal lining was probably caused by mechanical pressure (unknown suspect product role).

Manufacturer Narrative

Reference record (b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 9118694
• MDR Text Key: 165087552
• Report Number: 3010757606-2019-00654
• 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: consumer,foreign,health profe
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 062943
• Device Lot Number: 32145297
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE PEG TUBE, LOT # 32482246; ABBVIE PEG TUBE, LOT # 32482246
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 58