MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERIVAC KIT; PERICARDIOCENTESIS KIT

Catalog Number	K10T-05819
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to be returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
Account alleges that the pc drain was unable to enter the pericardium during the emergent effusion event.A stiffer dilator was opened and used.The drain was then successfully inserted and used.Patient was not hemodynamically stable at the time.
Additional Manufacturer Narrative
The device was not returned for evaluation.The complaint could not be confirmed and 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 to the manufacturer at a later date, the investigation will be reopened.

• Brand Name: PERIVAC KIT
• Common Device Name: PERICARDIOCENTESIS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 901 moorefield park dr; #103; north chesterfield VA 23236
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 901 moorefield park dr; #103; north chesterfield VA 23236
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 19608565
• Report Number: 1125782-2024-00002
• Device Sequence Number: 12321340
• Product Code: PPD
• UDI-Device Identifier: 00884450486139
• UDI-Public: 00884450486139
• Combination Product (Y/N): N
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 02/20/2026
• Device Catalogue Number: K10T-05819
• Device Lot Number: T2626122
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2023
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown