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

Model Number	00884450489437
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during the ablation phase of a procedure, the patient developed atrial tachycardia and hypotension.An echocardiogram was performed and found the myocardial tissue had been perforated and pericardial effusion.The perforation was sealed and the procedure continued.Another effusion developed and the procedure discontinued.Only the left pulmonary veins were isolated during the procedure.The patient has not suffered consequences due to this incident.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect medical device was not returned 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: HEARTSPAN® TRANSSEPTAL NEEDLE
• Common Device Name: TRANSSEPTAL 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: 16675234
• Report Number: 3010665433-2023-00031
• Device Sequence Number: 5282270
• Product Code: DRC
• UDI-Device Identifier: 00884450489437
• UDI-Public: 00884450489437
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: 09/20/2025
• Device Model Number: 00884450489437
• Device Catalogue Number: FND-020-01/B
• Device Lot Number: E2509243
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2025
• 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
• Patient Sex: Unknown