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

Model Number	G407211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/19/2021
Type of Reportable Event	Death
Event or Problem Description
Related manufacturer report numbers: 3008452825-2021-00169, 3008452825-2021-00179.During an atrial fibrillation (af) procedure, a tamponade occurred and the patient passed away following the procedure.After transseptal puncture, while manipulating the ablation catheter, the patient became hypotensive, and an ultrasound revealed a cardiac tamponade for which a drain was placed to stabilized the patient.The patient was stabilized and the procedure was completed.Following the procedure the patient passed away.There were no performance issues with any abbott products.
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.

• 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: 11574085
• Report Number: 3008452825-2021-00178
• Device Sequence Number: 11648800
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122587
• 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): 03/26/2021

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: 11/30/2023
• Device Model Number: G407211
• Device Catalogue Number: G407211
• Device Lot Number: 7773042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS INTRODUCER; TACTICATH SE; AGILIS INTRODUCER; TACTICATH SE
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 75