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

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 06/23/2015

Event Type  Injury  

Event Description

It was reported that during the mapping phase of an afib procedure, the patient was noted to have reduced movement of the heart on the fluoro and a pericardia! effusion was then noted on the uls (ice in use).The patient had a drop in blood pressure.No rf applications had been performed and all bwi products were working and set per protocol.The left atrium has only been mapped using the bwi lasso nav catheter.A pericardiocentesis was performed and is still in process, with a moderate return for blood from the pericardia! space, an exact amount is not known at this time.The patient was also administered iv fluids and norepinephrine for blood pressure support per anesthesia protocol.The physician user believes the injury resulted from performing the trans-septal puncture and bwi products are not responsible for the injury.The patient will remain overnight in the hospital for evaluation/monitoring.The following bwi products were in use/connected to the patient at the time of the injury: 1) c3 sn: (b)(6)); 2) stockert sn: (b)(6); 3) coolflow pump sn: (b)(6)) rmt catheter: nr7tcsiy, lot# 17196410m.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17517479
• MDR Text Key: 321050600
• Report Number: MW5124428
• 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: 07/08/2015

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: 08/11/2023
• Patient Sequence Number: 1