MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ TRANSSEPTAL NEEDLE, 89 CM LENGTH

Model Number	G407215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/10/2018
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 effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturer reference: 3008452825-2018-00336.During a pulmonary vein ablation procedure, a pericardial effusion occurred.During ablation on the left posterior wall, the patient became hypotensive and an effusion was noted and monitored using ice and medication was administered.During ablation of the right side of the pulmonary veins, the patient stabilized and the procedure was completed.A pericardiocentesis was performed, however bleeding continued.The hemoglobin level dropped from 8.0 to baseline to 5.0 during the pericardiocentesis and the patient was then transferred to the or for a sternal thoracotomy and blood transfusion.Surgery confirmed a perforation between the left superior vein and appendage, which was repaired to stabilize the patient.It was indicated the perforation occurred during transseptal with the agilis.The physician felt the dilator length contributed to the perforation.
Event or Problem Description
Additional related manufacturer reference: 3005334138-2018-00440.During a pulmonary vein ablation procedure, a pericardial effusion occurred.Following a difficult transseptal puncture, mapping was completed using an advisor catheter.During ablation with the tacticath contact force ablation catheter near the small left atrium, a steam pop occurred.Pericardial fluid was noted upon ultrasound monitoring.During ablation around the right veins, the pericardial fluid increased, and the pericardiocentesis was performed, however bleeding continued with a drop in the patient's hemoglobin requiring a blood transfusion.The patient was transferred to the or for a sternal thoracotomy.Surgery confirmed a perforation between the left superior vein and appendage, which was repaired to stabilize the patient.It was indicated by the user the length of the dilator used during transseptal access may have contributed to the perforation.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 89 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: 7915942
• Report Number: 3008452825-2018-00324
• Device Sequence Number: 940583
• Product Code: DRC
• UDI-Device Identifier: 05414734207225
• UDI-Public: 05414734207225
• 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
• Report Date (Section B): 11/21/2018

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: 10/31/2020
• Device Model Number: G407215
• Device Catalogue Number: G407215
• Device Lot Number: 6230266
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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 NXT STEERABLE INTRODUCER DUAL-REACH¿; TACTICATH CONTACT FORCE ABLATION CATHETER, SE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR