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 Death (1802); Sepsis (2067); No Code Available (3191)

Event Date 07/01/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).The device involved in the event was discarded and was not returned; therefore, a return sample evaluation is unable to be performed.Buried bumper and sepsis are known complications of a peg- j tube placement.(b)(4) was chosen to capture the event of buried bumper syndrome.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2018, 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, during complete peg tube replacement, a peg buried bumper was observed and was unable to extract using endoscopy.The stoma was infected due to the buried bumper.On (b)(6) 2020, the peg tube was emergently removed due to a weekend long 39 degree fever.A new stoma was performed and a feeding peg was placed that was not compatible with duodopa treatment.A nasogastric tube was inserted for gastric content drainage.On (b)(6) 2020, the neurologist reported the patient experienced generalized sepsis of gastric origin, her condition worsened and a fatal outcome was expected.She was sedated for analgesic control and received antibiotic therapy.On (b)(6) 2020, the patient died due to worsening of generalized sepsis of gastric origin.It was unknown if an autopsy was 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: 10351356
• MDR Text Key: 201228508
• Report Number: 3010757606-2020-00503
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 062941
• Device Lot Number: 32382417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2017
• 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 J TUBE, LOT #32162217
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 60