MAUDE Adverse Event Report: ST JUDE ST JUDE BRK NEEDLE; TROCAR

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

Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/19/2021

Event Type  malfunction  

Event Description

It was reported by the caller, clinical account specialist, that the patient suffered a pericardial effusion.The caller stated, "we had mapped the left atrium with the penta ray, a double transseptal was performed.The physician lost the second transseptal that is used for the ablation catheter.We mapped the left atrium, the patient was in afib, and we had mapped in afib.When we finished mapping, the physician wanted to do another transseptal so both the ablation and pentaray catheter could be used.The physician might have pushed too anteriorly because we noticed the patient's blood pressure drop.We also noticed the tamponade using intracardiac echo and a pericardiocentesis was performed.About 160 cc was removed.The patient was stable, the pressure was stable, and the patient was transferred out of the ep lab for overnight observation." the caller confirmed all 3 bwi catheters were in the body at the time of the event; however, no ablation was performed.The patient was hemodynamically stable at that time.The effusion was noticed through an intracardiac echo.The patient will stay overnight for observation.There was a suspected perforation in the anterior lower septum.It was confirmed with a soundstar.A pericardiocentesis was performed and 160cc fluid was removed.The tube was left in place.The procedure was abandoned.There was no evidence noted of any effusion present before the procedure.Soundstar catheter was in the atrium.The ablation catheter was in the right atrium.The pentaray was in the left atrium.The adverse event was discovered post use of the bwi products.The physician's cause of the adverse event was unknown.The outcome of the adverse event was fully recovered.The patient's gender is female.The patient had a previous ablation in (b)(6) 2020 for an atrial fibrillation.The patient's relevant history was xeralto.The transseptal puncture was performed with the st.Jude brk needle (lot: 7990386).The event occurred during the second transseptal phase.Before noting the cardiac tamponade, no ablation was performed.There was no evidence of a steam pop.The flow setting was set for the ablation catheter at low flow and for the penta ray catheter at low flow.There were no error messages observed on the biosense webster equipment during the procedure.The force visualization features used were graph, dashboard and vector.The color options used were tag index with surpoint.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ST JUDE BRK NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST JUDE
• MDR Report Key: 17529136
• MDR Text Key: 321406683
• Report Number: MW5136065
• 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: 08/31/2021

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