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

Model Number	407201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	12/17/2020
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 perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During an atrial tachycardia ablation procedure for the left atrium, while conducting the transseptal puncture, a perforation was noted on one of the leaflets of the aortic valve.After performing the transseptal puncture, when passing the guidewire through, the guidewire went down into the aorta.The perforation was diagnosed initially with ultrasound and then later via intracardiac echocardiogram.The procedure was then cancelled and no intervention was administered.There were no performance issues with the abbott product.

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: TRANSSEPTAL NEEDLE
• 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: 11154456
• Report Number: 3008452825-2020-00708
• Device Sequence Number: 3940916
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: (01)05414734205160(10)7641674(17)230731
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072278
• 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): 01/12/2021

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: 07/31/2023
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 7641674
• 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: 12/17/2020
• Initial Report FDA Received Date: 01/12/2021
• 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