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	Cardiac Perforation (2513)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a left ventricular tachycardia ablation procedure, the patient became hypotensive and a pericardial tamponade was noted.During the transseptal puncture, the patient began to cough at the moment the needle exited the sheath.No excessive force was noted to be seen on the ablation catheter.A pericardiocentesis was performed and the patient was stabilized.There were no performance issues with any abbott devices.
Event or Problem Description
During a left ventricular tachycardia ablation procedure, a cardia tamponade occurred.The patient's blood pressure decreased slowly during the procedure and when the sbp was at 59 mmhg a cardiac echo was performed and a cardiac tamponade was noted.A pericardiocentesis was performed and the patient was stabilized with the sbp returning to normal.The physician stated the perforation occurred during the transseptal puncture when the patient began to cough at the moment the needle exited the sheath.During the procedure there was no excessive force noted to be seen on the ablation catheter.There were no performance issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: b5, h2.
Additional Manufacturer Narrative
Additional information: g4, h2, h3, h6.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 cardia tamponade could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this 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: 10779728
• Report Number: 3008452825-2020-00546
• Device Sequence Number: 11034864
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup,Followup
• Report Date (Section B): 11/17/2020

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: 09/30/2022
• Device Model Number: G407212
• Device Catalogue Number: G407212
• Device Lot Number: 7212523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/09/2020; 11/10/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/03/2020; 11/17/2020
• 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