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

Catalog Number 062918

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 05/16/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.Catalog number is the similar u.S list number, the international list number is unknown the device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Cardiac arrest is a known complication of peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019 a patient in (b)(6) underwent a procedure for the replacement of a gastrostomy/jejunal catheter probe.It was reported with the assistance of a rat tooth forceps, the tube was positioned in the duodenum, despite several attempts impaired by the patient¿s anatomical condition.There were no immediate complications.During recovery, the patient reported some discomfort in the sternal and oropharyngeal region after awakening.There were no signs of subcutaneous emphysema.Her skin and mucosae were florid and acynotic.Oxygen saturation 85-90% under oxygen with persistent movement dyskinesia.Soft and depressible abdomen with bowel sounds present.She was given iv paracetamol and pantoprazole.An abdominal x-ray revealed a well-positioned peg probe in the duodenum.No signs of pneumoperitonitis.The patient revealed no signs of spontaneous emphysema; she was hemodynamically stable.She was admitted for observation in the neurology department.The patient was oriented and cooperative after arriving in the neurology department.Approximately 30 minutes after her arrival, the patient requested to go to the bathroom where she had a vigorous bowel movement accompanied with an altered state of consciousness.The patient was observed by intensive medicine with a glasgow coma scale of e2m2v2=3 and bradycardia of 30 beats/minute.The patient was unconscious and experienced bradycardia and was given atropine.The patient was intubated and ventilated with manual defibrillator.No breathing was noted despite measures instilled.The patient went into cardiac arrest and was unable to be reversed.Despite the measures instituted, the patient had a fatal cardiorespiratory arrest.

• 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: 8693566
• MDR Text Key: 147843788
• Report Number: 3010757606-2019-00387
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• 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): Required Intervention
• Patient Age: 72 YR