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

Catalog Number 062943

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

Patient Problems Inflammation (1932); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.A bezoar is a known complication of a j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2018 a patient in (b)(6) underwent a procedure for the re-placement of jejunal tube.On (b)(6) 2019 the following information was reported: on (b)(6) 2019, the patient was admitted to the hospital with abdominal pain.He was noted to have increased amylase and lipase.A clear liquid diet was started.No bowel obstruction was found, however the patient was noted to have a possible bezoar.A diagnosis of pancreatitis secondary to bezoar on duodopa pej causing intussusception was made.The patient previously experienced a bezoar approximately a year and a half prior.On (b)(6) 2019, the patient was discharged.Duodopa was withheld for four days and replaced with other parkinson's medications.On (b)(6) 2019, the patient was readmitted to the hospital with abdominal pain and distention.He was kept nil by mouth with nasal gastric tube in situ and iv fluids.Attempts were made to dissolve the bezoar with gastrograffin.Duodopa was temporarily stopped.A ct scan on (b)(6) 2019 showed the previous intussusception of jejuna and bezoar had both resolved and it also revealed a new small bowel obstruction distal to the pej tube tip and some adhesions.On (b)(6) 2019, the patient was discharged from the hospital.On (b)(6) 2019, the patient was again admitted under observation with a one week history of abdominal pain and distention, and constipation for one day.An x-ray indicated no suggestion of bowel obstruction and showed solid stool throughout colon and rectum.An aperient was given and the patient was discharged the same day with instructions to follow-up with a gastroenterologist.

Event Description

The following was reported on 20 nov 2019: the patient presented to the emergency department (ed) on (b)(6) 2019 complaining of upper abdominal pain, worsening in recent days.Patient was x-rayed.No bowel obstruction found.Pain relief was given.Patient instructed to attend the gastrology clinic the following week.Abdominal pain possibly due to moderate fecal matter in the colon.On(b)(6) 2019 the patient presented to the ed with severe upper abdominal pain, cramping and watery bowel motions.Admitted to the gastrology ward.Abdominal x-ray on (b)(6) 2019 showed moderate amount of fecal matter in colon.No bezoar.Pain relief and bowel aperients given.Patient remains in hospital for observation.

Manufacturer Narrative

Reference record (b)(4).

Manufacturer Narrative

Reference record (b)(4).

Event Description

A ct on (b)(6) 2019 showed recurrant 4.1 cm bezoar, mesentaric congestion/inflammation and pseudo-sacculation left pelvis - 8.3x7x11.Patient was discharged (b)(6) 2019.Awaiting organization of a replacement tube.

Event Description

It was reported the patient had peg-j tube changed on (b)(6) 2020 and that the intestinal tube had a bezoar the size of a plum.It was reported the patient received a halyard balloon replacement tube.

Manufacturer Narrative

Reference record (b)(4).

• 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: 9322624
• MDR Text Key: 174672107
• Report Number: 3010757606-2019-00818
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142816
• 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,Followup,Followup
• Report Date: 10/28/2019

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: 062943
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 11/27/2019; 02/18/2020
• Supplement Dates FDA Received: 11/27/2019; 12/18/2019; 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PEG TUBE, MANUFACTURER UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 79