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

Catalog Number 062941

Device Problem Positioning Failure (1158)

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 01/15/2020

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.(b)(4).Pneumoperitoneum and perforation are known complications of peg tube placement.The device was received.Investigation is not complete.A follow up report will be submitted upon completion of investigation.Refer mdr 3010757606-2020-00059 for linked report.

Event Description

On (b)(6) 2020, patient in (b)(6) underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.It was reported that there was a device quality complaint during the procedure.Report indicated that the external plastic cover of the trocar needle has been folded out of the skin and could not be inserted to the body.A different package of peg tube was tried but same problem happened.The physician used trocar needle of a non-abbvie tube and placed the abbvie peg tube.Endoscopy procedure was prolonged due to the problem in the tubes.After the endoscopy, the patient had abdominal pain and distension.Abdominal radiography was performed and accumulation of air in the abdomen was observed.Physician reported that the accumulation of air in the abdomen may be related to extended time of operation.Imaging test was performed for suspicion of perforation.Oral intake of the patient was discontinued, and the patient was followed up at the neurology unit where he was hospitalized.On (b)(6) 2020, the patient was started on total parenteral nutrition and was treated with analgesic parol (i.V).Duodopa infusion continued.On (b)(6) 2020, general surgery and internal medicine consultation was done.Additional information indicated that the patient underwent abdominal surgery on (b)(6) 2020 due to perforation and patient was monitored in intensive care unit.On (b)(6) 2020, duodopa treatment was interrupted.On (b)(6) 2020, patient's hospitalization continued.The patient has discharge and drains in the operating area.A nasogastric (ng) tube was placed and patient received feeding through it.Patient experienced edema of arms and legs.It was reported that abdominal distension, abdominal pain, air accumulation in the abdomen and discharge at the peg area were recovered on an unknown date.

Event Description

Sample evaluation completed.

Manufacturer Narrative

Reference record (b)(4).One used puncture cannula from peg kit was received at abbvie for examination.The sample was visually inspected.The cannula sheathing was observed to be folded, slightly retracted and wavy.No other damage was observed.Probable cause is most likely due to handling.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 9673418
• MDR Text Key: 185933185
• Report Number: 3010757606-2020-00060
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 062941
• Device Lot Number: 32312218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE J TUBE - 32204238
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 80