MAUDE Adverse Event Report: COOK MEDICAL COOK MEDICAL ENDRYS TRANSSEPTAL NEEDLE; TROCAR

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/28/2019

Event Type  Injury  

Event Description

It was reported that a 69-year-old male patient underwent an ablation procedure and suffered cardiac tamponade requiring pericardiocentesis.Additional information was received on (b)(6) 2019: physician's opinion regarding the cause of the adverse event is that it was procedure related, he suspected that the patient event occurred during transseptal puncture.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COOK MEDICAL ENDRYS TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 17533611
• MDR Text Key: 321144394
• Report Number: MW5140515
• 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: 02/13/2019

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
• Patient Age: 69 YR