MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number A-FASE-F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Dissection (2491); Cardiac Perforation (2513)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.

Event Description

During a ventricular tachycardia ablation procedure, an aortic puncture by the transseptal needle resulting in a pericardial effusion occurred.Following mapping of the left ventricle in a retroaortic approach, access to the left ventricle with a transeptal approach was attempted.After the transseptal puncture the patient became hypotensive.An echocardiograph confirmed a pericardial effusion.The pressure did not increase and the patient was brought to surgery, where the aorta was sutured to stabilize the patient.The next day the patient was stable with no visible consequences.There were no performance issues with any abbott device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9179222
• MDR Text Key: 162009179
• Report Number: 3008452825-2019-00497
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05415067020048
• UDI-Public: 05415067020048
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: A-FASE-F
• Device Lot Number: 7064483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other