MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERICARDIOCENTESIS KIT.8.3F (2.77 MM).40 CM (15.7").PIGTAIL.; FLUID DRAINAGE TRAY

Catalog Number	PC801/A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	02/23/2025
Type of Reportable Event	Death
Event or Problem Description
Medwatch received mw5167050 - the account alleges that in the cath lab while performing a pericardial fluid drainage procedure, the patient initially became hemodynamically unstable and a code blue was called.The code blue was terminated per the families request and the patient expired.A guidewire from pericardiocentesis kit was found damaged post procedure.
Additional Manufacturer Narrative
The suspect medical device is not expected to return 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.Should the device be returned later, the investigation will be reopened.

• Brand Name: PERICARDIOCENTESIS KIT.8.3F (2.77 MM).40 CM (15.7").PIGTAIL.
• Common Device Name: FLUID DRAINAGE TRAY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pky; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pky; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21584749
• Report Number: 1125782-2025-00002
• Device Sequence Number: 21151133
• Product Code: PXU
• UDI-Device Identifier: 00884450727911
• UDI-Public: 884450727911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: 07/26/2025
• Device Catalogue Number: PC801/A
• Device Lot Number: T2933767
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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: Death; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 107 KG