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

Catalog Number	FND-020-01/B
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Date of Event	02/22/2022
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 evaluation is complete.
Event or Problem Description
The account alleges that during an a-fib procedure, while under general anesthesia, during the mapping phase, the anesthesiologists noticed a depreciation of the vital parameters, such as blood pressure drop.The transesophageal echo showed fluid in the pericardium, thus a pericardiocentesis was performed for draining the blood.As the fluid drained, it was concluded that open chest surgery was needed for the bleeding to be stopped.The patient was transferred to the or and the surgeons found a perforation in the left atrial appendage (laa).The patient was transferred to the icu post-op.No additional patient consequence to report.
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: 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
• MDR Report Key: 13656743
• Report Number: 3010665433-2022-00020
• Device Sequence Number: 5046241
• Product Code: DRC
• UDI-Device Identifier: 00884450489437
• UDI-Public: 884450489437
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: N/A
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2024
• Device Catalogue Number: FND-020-01/B
• Device Lot Number: E2205473
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown