MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK; TROCAR

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/22/2018

Event Type  Injury  

Event Description

It was reported that during a pvi ablation, on crossing the septum with transesophageal echo (toe) guidance in an atrial fibrillation ablation case and the patient became hemodynamically unstable.Transesophageal echo (toe) revealed cardiac tamponade with a pericardial drainage.On more in-depth investigation with transesophageal echo (toe), it revealed a clot in the descending aorta with the thought of a puncture into the aorta with the transseptal needle.The bd710df282rt, a decapolar catheter was the only catheter in situ in the coronary sinus.The ablation catheter and lasso, although prepped were not inside the body.A priority one ambulance call was made to take the patient to (b)(6) to be met by a cardiothoracic surgeon.The cardiothoracic surgeon deemed the patient to be unstable to be moved and required surgery, opening the patient chest in the cath lab.Once in a stabilized condition, patient was then moved to (b)(6) main theatres.Caused delay in surgery.Male patient initials: (b)(6).Relevant patient pre-existing conditions: atrial fibrillation.Additional information was provided on the event on (b)(6) 2018.Physician's opinion regarding the cause of the adverse event is that it was procedure-related, specifically to transseptal puncture.It was reported that during transseptal phase, the patient became hemodynamically unstable.Cardiac tamponade was confirmed by transesophageal echo (toe).Transseptal puncture was performed with a brk1 transseptal needle and an sl1 8.5 fr sheath.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17529873
• MDR Text Key: 321083113
• Report Number: MW5136796
• 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: 11/19/2018

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