MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERICARDIOCENTESIS KIT; CATHETER, IRRIGATION

Catalog Number PC101/JPB

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  Injury  

Event Description

The account alleges that a patient had been receiving maintenance dialysis for end-stage renal failure due to nephrosclerosis.A scheduled pericardiocentesis was performed on (b)(6) 2022.After the aspiration of approximately 700 ml of pale-yellow pericardial fluid, the device was connected to a drainage bag.Approximately 70 ml had been removed per day.However, the device stopped draining on (b)(6) 2022 despite aspiration attempts.A catheter occlusion was suspected.On (b)(6) 2022 the catheter could not be removed due anatomical tortuosity.On the same day ((b)(6) 2022), surgical removal of the pc catheter was performed under general anesthesia and mini-thoracotomy of the sternum was completed.A fibrin sheath was noted to have attached around the drain and was removed by the surgeon.The patient tolerated the procedure and postsurgical recovery well.Extubating the patient was completed immediately after the surgical procedure.The patient was transferred from icu to a general ward the next day.Postop clinical course is favorable.Device was discarded after removal.

Manufacturer Narrative

The suspect device was discarded and will not be returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: PERICARDIOCENTESIS KIT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14645588
• MDR Text Key: 294757733
• Report Number: 1125782-2022-00008
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00884450015278
• UDI-Public: 884450015278
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2022

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: Health Professional
• Device Catalogue Number: PC101/JPB
• Device Lot Number: T2329148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Patient Outcome(s): Other