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

Catalog Number 062941

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/24/2023

Event Type  Death  

Event Description

On (b)(6) 2023, a patient in romania underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.The elderly patient with a generally deteriorated condition and history multiple disease processes was admitted to the neurology department for a re-evaluation.In consulation with the gastroenterologist, it was determined to change the peg-j system for an unknown reason.The procedure was done without incident or adverse events.The patient returned to the neurology department following the procedure.On (b)(6) 2023, the patient entered cardio-respiratory arrest.Physicians attempted rescuscitation maneuvers but without success.The patient passed away.While no allegation was made against abbvie's device in connection with the patient's death, due to the timing of the patient's death one day after peg-j placement procedure, abbvie is choosing to conservatively report this event.

Manufacturer Narrative

Reference number (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.The disposition of the device involved is unknown; therefore, it is unknown if a return sample evaluation can be performed.Procedural complications are labeled events.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
• 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: 18346824
• MDR Text Key: 330737444
• Report Number: 3010757606-2023-00853
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2023

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: Health Professional
• Device Catalogue Number: 062941
• Device Lot Number: 32421372
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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: ABBVIE INTESTINAL TUBE, LOT#32411362.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female