MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK-1¿ XS TRANSSEPTAL NEEDLE, 89 CM LENGTH; TROCAR

Model Number	G407216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
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 incident could not be conclusively determined. per the instructions for use, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
A day after the radio frequency procedure, a pericardial effusion in the left atrium on the posterior wall occurred during a transseptal puncture with the needle.The effusion was observed by an echocardiogram.A pericardiocentesis was performed and 500 cc of blood was drained.There were no performance issues with an abbott device.Concomitant devices include: tacticath se, inquiry, advisor, sl0 introducer.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 89 CM LENGTH
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 8405830
• Report Number: 3008452825-2019-00101
• Device Sequence Number: 420150
• Product Code: DRC
• UDI-Device Identifier: 05414734207232
• UDI-Public: 05414734207232
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122587
• 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
• Report Date (Section B): 03/08/2019

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: 12/31/2021
• Device Model Number: G407216
• Device Lot Number: 6817104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/08/2019
• 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: Required Intervention
• Patient Weight: 80