MAUDE Adverse Event Report: ST. JUDE ST. JUDE MEDICAL BRK 71 CM TRANSSEPTAL NEEDLE; TROCAR

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)

Patient Problem Pericardial Effusion (3271)

Event Date 06/28/2019

Event Type  Injury  

Event Description

It was reported by the caller that during the transseptal puncture the patient developed a pericardial effusion.A pericardiocentesis was performed in which s00cc's was removed the pericardial space.The patient was stabilized and transferred to the cardiac care unit for observation.Additional information was received which clarified that the patient's anatomy might have contributed to the event.Because the septum was thick, it required multiple attempts at cautery before getting across.Physician believed that the needle jumped after getting through.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ST. JUDE MEDICAL BRK 71 CM TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17528545
• MDR Text Key: 321065596
• Report Number: MW5135475
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1