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

Catalog Number DUODOPA INTESTINAL TUBE

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

Patient Problems Abscess (1690); Perforation (2001)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The device involved in the event was discarded and not returned; therefore, a return sample evaluation is unable to be performed.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in the usa underwent a procedure for the placement of percutaneous endoscopic jejunal tube (j-tube).The patient¿s wife stated that the j tube has been in place for a couple of years but it was unknown how long.On (b)(6) 2019, the patient experienced difficulty flushing the j-tube with a high pressure alarm and a neurologist referred the patient to the surgeon.On (b)(6) 2019, during an outpatient laparoscopic procedure, the surgeon found the j tube was knotted, migrated to the stoma and penetrated the stomach wall.Scar tissue was present which was growing around the j tube and there was an infected abscess.The surgeon attempted to remove the j tube but was not able to due to the scar tissue.The patient was then admitted to the hospital and began treatment with an unspecified intravenous antibiotic and an unknown analgesia.During the hospitalization, the patient experienced difficulty breathing and was admitted to the intensive care unit with poor appetite and lost a lot of weight.On (b)(6) 2019, the patient underwent surgery to cut through the scar tissue to remove the j tube.However, it was reported that a new j tube could not be placed due to the scar tissue in the patient¿s stomach.The surgeon created a new stoma to place a single lumen j tube directly into the jejunum (lot# 32463288) and the peg tube was kept in the original place.The patient was intubated as a precaution after the surgery but was extubated 15 hours later.On (b)(6) 2019, the patient resumed duopa therapy.However, the patient was not doing well in the hospital and on 19 nov 2019, the spouse took the patient home to a full-time caregiver.On (b)(6) 2019, the patient underwent placement of a peripheral inserted central catheter (picc).

• 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: 9478995
• MDR Text Key: 174665381
• Report Number: 3010757606-2019-00901
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/20/2019

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: Lay User/Patient
• Device Catalogue Number: DUODOPA INTESTINAL TUBE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/17/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR