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

Model Number G407211

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

Patient Problem Cardiac Perforation (2513)

Event Date 12/10/2020

Event Type  Injury  

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 cardiac tamponade could not be conclusively determined.

Event Description

During an atrial fibrillation ablation procedure, at the end a cardiac tamponade was noted via echocardiogram.A brk needle was used without issues during the procedure, although the transseptal puncture was noted to be difficult.The patient was noted to be stable and no pericardial drain was needed.The procedure was still completed.The perforation was believed to have occurred at the beginning of the procedure.

Manufacturer Narrative

Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK 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: 11015263
• MDR Text Key: 221792820
• Report Number: 3008452825-2020-00700
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• 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: 12/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: G407211
• Device Catalogue Number: G407211
• Device Lot Number: 7662652
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other