MAUDE Adverse Event Report: ST. JUDE ST. JUDE MEDICAL SL0-TRANSSEPTAL NEEDLE; TROCAR

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 11/12/2019

Event Type  Injury  

Event Description

It was reported that during a paroxysmal atrial fibrillation (afib) procedure it was noted that the patient suffered a pericardial effusion.There was no issue with the biosense webster, inc.Carto 3 system and there was no patient consequence.Additional information was received on 11/29/2019, and it was reported the complaint was reported to biosense webster, inc.For the pericardiai effusion.However, the pericardiai effusion was not caused by any biosense webster, inc.Devices.It was noted that the transseptal puncture is what led to the pericardiai effusion.The transseptal needle that was used was a st.Jude medical sl0 transseptal needle.(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 SL0-TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17526727
• MDR Text Key: 321152101
• Report Number: MW5133665
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1