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

Catalog Number 062910

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

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

Event Date 01/01/2021

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).(b)(4).The device manufacturer and lot number of the peg tube involved in this event was not provided by the complainant.Therefore, it is unknown if the tubing involved was the abbvie peg tube.Abbvie has chosen to report this event due to the potential that the peg tube involved could have been the abbvie peg tube.The device involved in the event was not returned, it remains implanted; therefore a return sample evaluation is unable to be performed.Pneumoperitoneum is a known complication of a peg tube placement.The instructions for use indicate, to secure the peg tube, pull on the abbvie peg tube until elastic resistance is felt and keep under tension and abbvie peg tube should 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) 2021, the physician provided slide prepared for a presentation that included the event.On an unknown date, the patient underwent procedure for the placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.The patient had a stooped posture.The report indicated that the external fixation plate was loose and it was tightened.The peg-j tube had managed to move.After an unspecified period of time, the patient experienced abdominal pain, symptoms of infection, and abdomen was soft.Unspecified imaging study indicated air and fluid in the abdominal cavity.The patient received conservative treatment in the emergency department.The report indicated that the patient's condition worsened and patient died.The primary reporter assessed that the stooped posture played a role in the development of the situation and advised to be cautious in placing peg-tube for a stooped patient in future.

• 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: 11339591
• MDR Text Key: 232246071
• Report Number: 3010757606-2021-00116
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2021
• 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 UNK
• Patient Outcome(s): Required Intervention