MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HEARTSPAN® TRANSSEPTAL NEEDLE; TROCAR NEEDLE

Catalog Number	FND-020-02/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Pericardial Effusion (3271)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the investigation is complete.
Event or Problem Description
The account alleges that post-transeptal puncture, during an ablation procedure for atrial tachycardia, pericardial effusion was noted, and cardiac perforation could not be ruled out.The physician advanced an ice catheter and ordered an echo study to confirm the effusion was developing.Pericardial perforation was ruled out at this time.An emergent pericardiocentesis [pc] was performed.During the pc, the patient experienced ventricular tachycardia [vt] arrhythmia so the patient was successfully defibrillated to normal sinus rhythm.Post pc drainage placement, 700cc of fluid was successfully removed from the patient pericardial space.The patient was returned to the unit for observation in stable condition.
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: HEARTSPAN® TRANSSEPTAL NEEDLE
• Common Device Name: TROCAR NEEDLE
• 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
• MDR Report Key: 18313049
• Report Number: 3010665433-2023-00098
• Device Sequence Number: 12418692
• Product Code: DRC
• UDI-Device Identifier: 00884450451717
• UDI-Public: 884450451717
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 12/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2026
• Device Catalogue Number: FND-020-02/B
• Device Lot Number: E2708275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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