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

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

It was reported that during the transseptal, the needle was advanced too posterior and may have gone into another vessel.The procedure was halted and the patient was stable with no apparent affects from the transseptal.No treatment was performed and no treatment was anticipated.The transseptal needle was a brk.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK-TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17526881
• MDR Text Key: 321246745
• Report Number: MW5133818
• 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: 04/15/2014

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