MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	G407212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	01/21/2021
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.
Event or Problem Description
During the ventricular tachycardia ablation procedure, there was an aortic perforation.During transseptal puncture, there was a change in arterial pressure.An echocardiogram showed a perforation of the aorta with limited blood collection on the aorta wall.A computerized tomography scan was taken and confirmed that there were no adverse consequences to the patient.The procedure was cancelled, and no additional treatment was necessary.There were no performance issues with any abbott device.

• Brand Name: BRK-1 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: 11275821
• Report Number: 3008452825-2021-00042
• Device Sequence Number: 4607324
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K122587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: G407212
• Device Catalogue Number: G407212
• Device Lot Number: 7714340
• 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: 01/21/2021
• Initial Report FDA Received Date: 02/03/2021
• 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: Other