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

Catalog Number 062943

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

Patient Problem Bowel Perforation (2668)

Event Date 07/01/2022

Event Type  Injury  

Event Description

In (b)(6) 2020, on an unknown date a patient in france underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, it was reported that the patient experienced a tear in the jejunal wall by the distal end of the intestinal tube.It was reported that the tube exited the intestine through the anus and patient underwent insertion of new j tube.

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was removed from the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Catalog number is the similar us list number, the international list number is unknown intestinal perforation is a known complication of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Manufacturer Narrative

Reference record (b)(4).

Event Description

On an unknown date, it was reported that the patient's j tube was removed endoscopically.The intestinal perforation was confirmed.It was reported in the operative report that " "35 cm from the anal margin, there is a fistulous orifice through which the peg flange and the jejunal tube emerge".The patient did not have new tubing placed.

• 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: 15235269
• MDR Text Key: 297990413
• Report Number: 3010757606-2022-00543
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062943
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PEG TUBE, LOT # UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose