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

Catalog Number	FND-020-01/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/20/2021
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 atrial fibrillation case, a pericardial effusion was noticed.It is thought that the heartspan transseptal needle either "nicked" the aorta or the roof of the left atrium.After isolating three of the pulmonary veins, there was a drop in blood pressure on the patient.The pericardial effusion was confirmed by ice and echo.Medical intervention was a pericardiocentesis procedure with 1.5 l of fluid being removed."kcentra" prothrombin was injected through the central iv line and "floseal" thrombin gel foam was also injected into the patient's pericardial sac.After about 30 minutes, another transthoracic echo was performed for confirmation and the patient was then taken into icu for further monitoring.The patient was reported to be in stable condition.No further 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.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.

• Brand Name: HEARTSPAN TRANSSEPTAL NEEDLE
• Common Device Name: TRANSSEPTAL TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 12239771
• Report Number: 3010665433-2021-00059
• Device Sequence Number: 19867628
• Product Code: DRC
• UDI-Device Identifier: 00884450489437
• UDI-Public: 884450489437
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 04/27/2024
• Device Catalogue Number: FND-020-01/B
• Device Lot Number: E2113830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention