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 Problems Aspiration/Inhalation (1725); Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/25/2021

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.(b)(4).Post-procedural complications are known complications of a peg-j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021, 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) 2021, the patient experienced asphyxia and died.It was unknown if an autopsy was performed.There was no allegation by the physician that the tubing contributed to the asphyxia and death; however, abbvie has chosen to report these events since they occurred within the postoperative period.

Manufacturer Narrative

Reference record (b)(4).

Event Description

Additional information received from the physician reported that on (b)(6) 2021, the patient vomited and was found lying in front of the door in a state of cardio-respiratory arrest.The patient was resuscitated, but the breathing was unstable.Convulsions and anoxic encephalopathy were suspected.On (b)(6) 2021, dopamine hydrochloride and noradrenaline were administered to the patient to maintain blood pressure.On (b)(6) 2021, the patient experienced cardiac arrest.After 8 doses of adrenaline were administered over a period of time, the death of the patient was confirmed.The physician could not rule out the possibility that the peg-j placement led to cardio-respiratory arrest with vomiting and aspiration.The physician could also not rule out that the vomiting and subsequent aspiration could have been caused by a lethal arrhythmia.A clear distinction of cause was difficult.

• 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: 12343756
• MDR Text Key: 267311778
• Report Number: 3010757606-2021-00578
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 062941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: J-TUBE - UNKNOWN MANUFACTURER AND LOT #; J-TUBE - UNKNOWN MANUFACTURER AND LOT #
• Patient Outcome(s): Other
• Patient Age: 80 YR