MAUDE Adverse Event Report: MEDTRONIC INC. TRANSSEPTAL NEEDLE; TROCAR

Patient Problems Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

During the procedure, prior tachycardia mapping, physician used a (b)(6) needle (medtronic) to perform the transeptal and noted that it was very difficult.The patient became hypotensive and an offset on qrs (segment st) appeared on ecg during the transeptal.The physician decided to wait for the qrs to recover a normal shape before continuing the procedure.After stabilization, mapping was done using the advisor hd grid mapping catheter and ablation was performed with the tacticath ablation catheter.It was clear for the physician (b)(6) devices are not the cause of this issue because he did use an (b)(6) needle for the transeptal.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 17490791
• MDR Text Key: 320771916
• Report Number: MW5122783
• 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: 08/07/2023

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2023
• Patient Sequence Number: 1