MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HEARTSPAN TRANSSEPTAL NEEDLE; TROCAR

Model Number D-1299-05-S

Device Problem Malposition of Device (2616)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/16/2017

Event Type  malfunction  

Event Description

During preparation of a pvi case, the transseptal needle was misplaced at the septal wall and was therefore introduced to the aorta instead of the left atrium.Fluoroscopy showed the transseptal needle inside the aorta.Drop of patient's oxygen saturation required termination of the procedure.Intervention stabilized the patient.Needle was removed from the patient.Patient was still in stable condition.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HEARTSPAN TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 17535551
• MDR Text Key: 321473198
• Report Number: MW5142447
• 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: 06/08/2017

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
• Device Model Number: D-1299-05-S
• Patient Sequence Number: 1