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

Catalog Number 062941

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

Patient Problems Gastrointestinal Hemorrhage (4476); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient in ireland underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube in interventional radiology.For unknown reasons the peg-j tube could not be advanced at that time.The patient remained in the hospital and the peg-j tube was placed endoscopically the next day, on (b)(6) 2023.On (b)(6) 2023, it was reported that the patient was quite sick, having severe abdominal pain over the weekend and vomit x3 of coffee ground emesis.Blood tests indicated the patient's crp and wcc were high.The patient was being treated for pneumoperitoneum secondary to the peg tube coming dislodged from the abdominal wall.The plan of care included: 1.Madopar po in replacement of duodopa, duodopa on hold for interim.2.Ng free drainage insitu.3.Commence iv tazocin.4.Repeat ct abdomen this pm.5.Commence pabrinex.On (b)(6) 2023, the patient was seen by the surgical team and gastroenterologist.The peg was not to be mobilized and a picc was being placed in order to start tpn.On (b)(6) 2023, the patient was taken to the or where a mini laparotomy was performed due to the peg tube being dislodged from the abdominal wall.The wall was sutured and the tubing was secured.Peg and peg-j remained in situ.The patient remained in the surgical department.Multiple attempts to obtain additional information were made, but no information was provided regarding the origin of the patient's internal bleed, the patients medical history or concomitant medications.

Manufacturer Narrative

Reference number (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation cannot be performed.H6 code of 4581 was chosen to capture the event of pneumopertioneum.Per the instructions for use (ifu): to secure the peg tube, the peg tube should be pulled until elastic resistance is felt, keep under tension, secure fixation plate into position using the clip, and remain under moderate tension for 24-72 hours to promote good adherence to the stomach wall to the inner abdominal wall.A pneumoperitoneum and gastric bleed are a 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

Additional information received on 19 oct 2023: it was reported on (b)(6) 2023 by the neurology intern that the patient tested positive for c-diff.Abbvie is reporting this post procedural complication of hospitalization conservatively.It was not indicated what caused the c-diff or what treatement was provided, but relationship of this complication to the previously reported post procedural complications could not be ruled out.

Manufacturer Narrative

H6 code of 4581 was chosen to capture the event of "complication of hospitalization post procedure." complications post procedurally are labeled events.

• 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: 18069750
• MDR Text Key: 327352976
• Report Number: 3010757606-2023-00743
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 062941
• Device Lot Number: 32421362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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 INTESTINAL TUBE, LOT#32051352.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose