MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TSX TRANSSEPTAL DELIVERY SYSTEM; TROCAR

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported a pericardial tamponade occurred during transseptal puncture from right to left atrium for a afib/ pulmonary vein isolation procedure.The patient had a difficult heart anatomy and the area where the transeptal puncture could be done was very limited.The aorta of the patient was big and pushing against the right atrial wall.After the puncture, the blood pressure was decreasing steadily.The operating physician was calling other physicians.After performing a tee, the physician realized that there is a pericardial tamponade.Then the physicians laid a drainage.After a while, the patient¿s blood pressure was stabilized.The patient was then prepared to go back to the hospital room, where he was planned to stay for 2 more day for supervision.No surgery needed.Bsx transeptal needle and sheet (sheath) were used for transseptal puncture.A webster cs and thermocool stsf catheter were in the heart (in cs and right atrium) during the event, but they were not navigated during the transseptal puncture.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TSX TRANSSEPTAL DELIVERY SYSTEM
• Type of Device: TROCAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18447114
• MDR Text Key: 332148158
• Report Number: MW5149795
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Patient Sequence Number: 1