MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number	407201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of an atrial fibrillation ablation procedure, a pericardial effusion was noted.Transseptal puncture was complicated and an echocardiogram was performed regularly throughout the procedure.Just after transseptal puncture, an echocardiogram was done, and the procedure continued.The patient received heparin and when geometry was finished, and a pericardial effusion was noted via echocardiogram.However, the user decided to continue the procedure.When the pulmonary veins were isolated, the procedure was stopped as the effusion was larger, and the patient became hypotensive.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any abbott devices.
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 perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE, 71 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: 11214407
• Report Number: 3008452825-2021-00036
• Device Sequence Number: 11635022
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K072278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 09/30/2023
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 7698837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 01/26/2021
• 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: Required Intervention