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

Catalog Number 062945

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

Patient Problems Perforation (2001); Aspiration Pneumonitis (4455); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2022

Event Type  Death  

Manufacturer Narrative

Reference number (b)(4).Catalog number is the international list number which is similar to us list number of 062912.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia and suspected gastric perforation are known complications of a peg- j tube placement.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2022, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, the patient experienced aspiration pneumonia and suspected gastric perforation.On unknown date, the patient died.The neurologist reported the death of the patient caused by aspiration pneumonia and suspected gastric perforation post positioning of the device peg j tube.He had not started treatment with duodopa.The neurologist stated the death was not related to the peg/j tubing nor to the device placement procedure.

Manufacturer Narrative

Reference number (b)(4).Catalog number is the international list number which is similar to us list number of 062912.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia and suspected gastric perforation are known complications of a peg- j tube placement.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2022, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, the patient experienced aspiration pneumonia and suspected gastric perforation.On unknown date, the patient died.The neurologist reported the death of the patient caused by aspiration pneumonia and suspected gastric perforation post positioning of the device peg j tube.He had not started treatment with duodopa.The neurologist stated the death was not related to the peg/j tubing nor to the device placement procedure.

• 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: 13573195
• MDR Text Key: 285917822
• Report Number: 3010757606-2022-00104
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 062945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• 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, UNKNOWN MANUFACTURER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male