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); Internal Organ Perforation (1987); No Code Available (3191)

Event Date 09/24/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).Catalog number is the international list number which is similar to us list number of (b)(4).The device involved in the event remained implanted in the patient; therefore, a return sample evaluation is unable to be performed.(b)(4) was chosen to capture the event of buried bumper syndrome.A buried bumper is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2020, the patient underwent endoscopy to replace the peg-j tubing.During the endoscopy, buried bumper syndrome was discovered.The physician was unable to remove the peg tube, but was able to replace the j-tube.A surgical removal and replacement of the peg tubing will be scheduled at a later date.

Event Description

On (b)(6) 2020, went to the emergency room (er) due to vomiting, anuria, and fever.On (b)(6) 2020, and abdominal computed tomography (ct) scan was performed, which showed a gastric perforation.The patient underwent surgery on (b)(6) 2020 for the gastric perforation due to the buried bumper a peg tube was placed to maintain the stoma.

Manufacturer Narrative

Reference record (b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2020, after the surgery to repair the gastric perforation and placement of a peg tube to keep the stoma open.The patient remained hyperthermic.The patient received enteral feedings through the peg tube.The patient's condition deteriorated.And on (b)(6) 2020, the patient died.The cause of death was reported as gastric perforation.It was unknown, if an autopsy was performed.

Manufacturer Narrative

Reference record (b)(4).Additional information added to b2, b5, h1, h6.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
• MDR Report Key: 10678074
• MDR Text Key: 211298788
• Report Number: 3010757606-2020-00654
• 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,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 062941
• Device Lot Number: 32464267
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE J-TUBE - LOT # 32044209; ABBVIE J-TUBE - LOT # 32044209
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 72 YR