MAUDE Adverse Event Report: BOSTON SCIENTIFIC TSX TRANSSEPTAL SHEATH; TROCAR

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/20/2020

Event Type  Injury  

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure and developed thrombosis requiring no interventions.Additional information was received on 03/25/2020: physician's opinion regarding the cause of the adverse event is that it was due to the boston scientific tsx transseptal sheath (non-bwi product) and occurred before any radio frequency delivery was done.The suspected device is the boston scientific tsx transseptal sheath.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TSX TRANSSEPTAL SHEATH
• Type of Device: TROCAR
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17536152
• MDR Text Key: 321158953
• Report Number: MW5143042
• 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: 04/24/2020

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