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

Catalog Number 062941

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

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

Event Date 01/27/2022

Event Type  Injury  

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.On (b)(6) 2022, the patient went to the hospital to perform the first post peg treatment.She presented with acute pain in abdominal area, irradiation to the left shoulder, hypotension, respiratory difficult, and was taken to the emergency room.A ct scan of the chest, abdomen, and a blood test was performed and the patient was diagnosed with a pneumoperitoneum and an intestinal perforation.The patient was taken to the operating room for an emergency intervention.The gastroenterologist confirmed that the patient had a dilated puncture point in the gastric mucosa which was sutured and invaginated to reinforce the channel through which the tube passes.A nasogastric tube with a slope was placed in the patient to empty gastric content and contrast.It was reported that the patient was doing well post operation, and has recovered from the intervention.

Manufacturer Narrative

Reference record (b)(4).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.Catalog number is the international list number which is similar to us list number of 062910.Intestinal perforation, and pneumoperitoneum are known complications of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Manufacturer Narrative

Reference record (b)(4).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.Catalog number is the international list number which is similar to us list number of 062910.Intestinal perforation, and pneumoperitoneum are known complications of a peg tube/ j-tube placement.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.On (b)(6) 2022, the patient went to the hospital to perform the first post peg treatment.She presented with acute pain in abdominal area, irradiation to the left shoulder, hypotension, respiratory difficult, and was taken to the emergency room.A ct scan of the chest, abdomen, and a blood test was performed and the patient was diagnosed with a pneumoperitoneum and an intestinal perforation.The patient was taken to the operating room for an emergency intervention.The gastroenterologist confirmed that the patient had a dilated puncture point in the gastric mucosa which was sutured and invaginated to reinforce the channel through which the tube passes.A nasogastric tube with a slope was placed in the patient to empty gastric content and contrast.It was reported that the patient was doing well post operation, and has recovered from the intervention.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE MEDICAL DEVICE CENTRE; 1675 south lakeside drive; waukegan; 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: 13573282
• MDR Text Key: 286070935
• Report Number: 3010757606-2022-00107
• 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: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Nurse
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 062941
• Device Lot Number: 32361129
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/21/2022
• Date Device Manufactured: 09/03/2019
• 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 # 32471109
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 45 KG