MAUDE Adverse Event Report: ARGON WIRE, GUIDE, CATHETER

Model Number GUIDEWIRE

Device Problem Difficult to Insert (1316)

Patient Problem Septic Shock (2068)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the anterior wall of the left ventricle was perforated when inserting the argon guide wire and the patient's blood pressure decreased sharply and the patient went into a state of shock.The ultrasound revealed increase of pericardia! effusion.A thoracotomy was performed to repair the perforation while using the percutaneous cardiopulmonary support (pcps).No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WIRE, GUIDE, CATHETER
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARGON
• MDR Report Key: 17523876
• MDR Text Key: 321132189
• Report Number: MW5130824
• Device Sequence Number: 1
• Product Code: DQX
• 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: 12/05/2018

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: GUIDEWIRE
• Patient Sequence Number: 1