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

Catalog Number 062910

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Peritonitis (2252); No Code Available (3191)

Event Date 07/25/2019

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the similar us list number, the international list number is unknown.The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The disposition of the device involved in the event was unknown; therefore, a return sample evaluation is unable to be performed.Peritonitis and pneumoperitoneum are known complications of a peg tube/ j-tube placement.Per instructions for use (ifu), the peg tube should be pulled until elastic resistance is felt, kept under tension, fixation plate should be secured into position using the clip, and remain under moderate tension for 24-72 hours to promote good adherence to the stomach wall to the inner abdominal wall.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, 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) 2019, an abdominal x-ray was performed, showing the j-tube curled in the stomach.On (b)(6) 2019, an abdominal ct scan was performed, showing extensive free air and the peg tube not fixed against the abdominal wall.On (b)(6) 2019, another abdominal ct scan was performed, showing air and fluid in the abdomen.On an unknown date, a gastroscopy was performed, showing a large ileus.On (b)(6) 2019, the patient died.The causes of death were reported as extensive free air and moisture in the abdomen and infection in the peritoneal cavity after the peg placement.An autopsy was not performed.

Manufacturer Narrative

Reference record (b)(4).

Event Description

On (b)(6) 2019, 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) 2019, an abdominal x-ray was performed, showing the j-tube curled in the stomach.On (b)(6) 2019, an abdominal ct scan was performed, showing extensive free air and the peg tube not fixed against the abdominal wall.On (b)(6) 2019, another abdominal ct scan was performed, showing air and fluid in the abdomen.On an unknown date, a gastroscopy was performed, showing a large ileus.On (b)(6) 2019, the patient died.The causes of death were reported as extensive free air and moisture in the abdomen and infection in the peritoneal cavity after the peg placement.An autopsy was not performed.

• 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: 9280863
• MDR Text Key: 165109459
• Report Number: 3010757606-2019-00770
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142793
• 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,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 062910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• 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
• Treatment: J-TUBE - MANUFACTURER AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 80 YR
• Patient Weight: 57