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

Event Date 01/01/2023

Event Type  Injury  

Event Description

On an unknown date, a patient in italy underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, the patient experienced intestinal perforation after a ct scan.Externally, there was little tube and the gastric and jejunal ports were adherent to the skin as a probable loss of the external bumper.The gastric intraluminal bumper was in the decubitus bulb and pulled from the first perforation by the intestinal tube.The intestinal tube was impacted and covered by a bezoar/food debris at the jejunal level.A second perforation was at the bulbar level with the bulb distorted and crumpled by the heavy traction.With foreign body forceps, the bumper was removed from the bulb, positioning it in the gastric cavity allowing an endoscopic view to the surgeons.A first gastro-jejunal anastomosis was performed resecting part of the antrum and the proximal bulb/duodenum, and a second distal jejunal resection at the level of the second perforation.The two external ports and the residual tube remained in place as a precaution at the behest of the surgeons so as not to lose the stoma.The patient was hospitalized in intensive care due to peritonitis from ingestion and gastric fluids in the post-perforation peritoneum.

Manufacturer Narrative

Reference number: (b)(4).Catalog number in catalog#: is the similar us list number, the international list number is unknown.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.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 remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Bezoar, intestinal perforation and peritonitis are known complications of a peg- j tube placement.Code of 4581 was chosen to capture the event of bezoar.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: 16375158
• MDR Text Key: 309526163
• Report Number: 3010757606-2023-00116
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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: PEG TUBE, UNKNOWN MANUFACTURER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male