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 Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888); Pneumonia (2011)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained implanted in the patient; therefore, a return sample evaluation is unable to be performed.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021 a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.It was reported that during the introduction of the peg tube, the trocar accidentally injured the gastric wall contralateral to the stoma and to the incision point causing moderate bleeding in the gastric cavity.In the afternoon, the patient¿s condition was aggravated due to an upper gastrointestinal bleed.Patient was transferred to a referral hospital, intubated and sedated.Bleeding was initially controlled with atropine injection into the gastric mucosa, but ultimately an emergency endoscopy with clips being placed was done to stop the bleeding.Throughout the intervention, the patient vomited significantly which required aspiration.The peg-j tube remained correctly placed and duodopa was administered.The patient was transferred to the intensive care unit.A chest x-ray revealed broncho aspiration.The patient received antibiotics, intravenous analgesia, fluid therapy, oxygen therapy, and nebulizations.Nothing per oral regime.On 07 may the bleeding was controlled, patient remained intubated and sedated.11 may there was general improvement of the patient, was in a room without assistance of breathing machine.Duodopa treatment continued.(b)(6) without incident the same internal tube was repositioned in the small intestine and the bleeding resolved.All the intravenous treatment discontinued.The patient is stable without pain, with good tolerance to the oral antibiotic medication and to the oral intake.Ambulation started.Recovering slowly from pneumonia caused by aspiration.Tomorrow patient to be discharged to the residence.

• 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: 11880109
• MDR Text Key: 261811116
• Report Number: 3010757606-2021-00355
• 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: foreign,health professional,o
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/25/2021

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: 062941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 108