MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HEARTLIGHT®; TROCAR

Catalog Number FST-002-00/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a pvi procedure where a steerable sheath was used, the patient had a pericardial effusion.There was no device deficiency reported.No additional information available.

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: HEARTLIGHT®
• Type of Device: TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17680506
• MDR Text Key: 322606982
• Report Number: 3010665433-2023-00074
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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: FST-002-00/A
• Device Lot Number: E2581636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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): Required Intervention; Life Threatening