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

Model Number	A-FASE-F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Dissection (2491); Cardiac Perforation (2513)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3008452825-2019-00497
• Device Sequence Number: 2550340
• Product Code: DRC
• UDI-Device Identifier: 05415067020048
• UDI-Public: 05415067020048
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 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
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: Other