MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HEARTSPAN®; TRANSSEPTAL NEEDLE KIT AND STYLET

Catalog Number	FND-019-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Perforation (2513); Pericardial Effusion (3271); Asystole (4442)
Date of Event	10/21/2025
Type of Reportable Event	Death
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 review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
During an atrial fibrillation procedure for pulmonary vein isolation (pvi), a pericardial effusion occurred and the patient expired.The diagnostic catheters were placed in the bundle of his and right atrium coronary sinus position and transseptal puncture was done successfully.Afterwards the mapping catheter was placed in the left atrium and steering was noted to be difficult.A cardiac ultrasound showed a pericardial effusion in the patient.A pericardiocentesis was then performed.During the next hour approximately 1.5 liters blood were withdrawn from the pericardium.The emergency team entered the room and soon the patient showed asystole.The emergency team began with cpr, however the patient did not recover and expired in the cath lab.The physician stated that there were no product performance issues with any abbott products used in this case.According to the physician the cause of the effusion and of the patient's death are not clearly known but that the perforation could have potentially occurred after transseptal puncture on the left atrium roof.

• Brand Name: HEARTSPAN®
• Common Device Name: TRANSSEPTAL NEEDLE KIT AND STYLET
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23645273
• Report Number: 1721504-2025-00639
• Device Sequence Number: 9829841
• Product Code: DRC
• UDI-Device Identifier: 00884450489345
• UDI-Public: 00884450489345
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: FND-019-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown