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

Catalog Number 062912

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

Patient Problems Sepsis (2067); Peritonitis (2252); Bowel Perforation (2668); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062912.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.A pneumoperitoneum and bowel perforation are known complication of a peg tube/ j-tube placement.Health effect clinical code of 4581 was chosen to capture the event of pneumoperitoneum.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2022 a patient in the usa underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.On (b)(6) 2022 during the tubing placement of 20fr peg tube, the thread broke away from the fixation loop while pulling the peg through the stomach / abdominal wall.It was reported that the thread broke twice and caused the tubing placement procedure to extend.The patient reported that after eating 24 hours after the tubing placement, he experienced stomach cramps, whole body stiffness and intense pain.The patient was diagnosed with a pneumoperitoneum and treated with 800mg of ibuprofen.After little improvement, the patient went to the emergency room for intense pain.A ct scan and xray revealed a leak of acid and bacteria into the stomach resulting in sepsis and the patient was treated with intravenous antibiotics.On (b)(6) 2022, the patient was discharged to a care facility for 4 to 5 days.At the time of report, the patient was improving.

Event Description

Additional information received on 03 oct 2022: on (b)(6) 2022 the patient underwent a surgical procedure to close the "hole in the stomach" and clean out the sepsis.It was reported that the patient was treated with multiple unspecified intravenous antibiotics and the peg and j tubes were replaced.The patient reported that he was incoherent while in the hospital for 10 days.On (b)(6) 2022, the patient started duopa therapy.

Manufacturer Narrative

Reference record (b)(4).It was unknown if the device involved in the event was discarded or will be returned; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.Peritonitis / sepsis are known complication of a peg tube/ j-tube placement.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
• 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: 15283788
• MDR Text Key: 298492891
• Report Number: 3010757606-2022-00560
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

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: 062912
• Device Lot Number: 32401431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBVIE J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male