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

Model Number G407212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.

Event Description

Related manufacturer reference: 3008452825-2019-00263, 2030404-2019-00040, 2182269-2019-00076.During a pulmonary vein isolation procedure, a pericardial effusion occurred.There were no patient symptoms.The effusion was diagnosed by transthoracic echocardiogram.The left atrium was reached and the procedure was able to be completed.The patient was stable throughout the procedure and after being followed under intensive care for observation.It was indicated the puncture was difficult and the aortic bulb may have been punctured.There was no indication that an abbott device caused the event, but the cause could not be confirmed.There were no performance issues with any abbott device.

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 pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.Further information regarding the event were requested but not received.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: 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: 8669861
• MDR Text Key: 147028538
• Report Number: 3008452825-2019-00262
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (y/n): N
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: G407212
• Device Lot Number: 6926561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS¿ NXT STEERABLE INTRODUCER; INQUIRY¿ STEERABLE EP CATHETER; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER; AGILIS¿ NXT STEERABLE INTRODUCER; INQUIRY¿ STEERABLE EP CATHETER; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER
• Patient Outcome(s): Other