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

Catalog Number	PC101/JPB
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1125782-2022-00008
• Device Sequence Number: 5574592
• Product Code: GBX
• UDI-Device Identifier: 00884450015278
• UDI-Public: 884450015278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2025
• Device Catalogue Number: PC101/JPB
• Device Lot Number: T2329148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown