MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERCARDIOCENTESIS KIT.STERILE; CUSTOM KIT

Catalog Number	K10T-05816
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a scheduled pericardiocentesis procedure in the ep lab for an elderly female patient diagnosed with cardiac tamponade was successfully completed.The access approach was "apical" and was completed under fluoroscopy.Both the guidewire and dilator within the kit were used during the procedure to acquire pc catheter access.No anatomical variations were experienced or difficulties in infiltrating the patient's pericardium.The account alleges that during the pc catheter removal, resistance was experienced by the physician.Additional interventions to remove the catheter safely were initiated however, the tip of the pig tail drainage catheter detached, just distal to the marker band within the patient's pericardium.Ct surgery assisted in trying to remove the foreign body from the patient.A vascular snare device was utilized unsuccessfully.A drainage tube was placed, and the patient was transferred to icu for thoracic surgery consultation.It is likely surgical intervention [sternotomy] will be needed if the patient can tolerate the procedure.All parts of the pc catheter have been discarded.Nothing available to return for investigation.The patient has since then recovered and has been discharged to home.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PERCARDIOCENTESIS KIT.STERILE
• Common Device Name: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• MDR Report Key: 12174195
• Report Number: 1125782-2021-00001
• Device Sequence Number: 887619
• Product Code: PXU
• UDI-Device Identifier: 00884450054017
• UDI-Public: 884450054017
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: K10T-05816
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 82