MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number TRUWAVE X3

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Female patient with severe aortic stenosis was admitted with acute coronary syndrome requiring urgent stenting of (l) anterior descending artery and candidate for transcatheter aortic valve replacement rather than surgical aortic valve replacement due to age and cannot come of plavix.Triple transducer (this is one that is never connected to a patient) line would flush only through the arterial line.The pa (yellow) an dcvp (blue) lines would not flush.A new device was opened and used for patient care.

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 4151102
• MDR Text Key: 4785075
• Report Number: 4151102
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: TRUWAVE X3
• Device Lot Number: 59750719
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2014
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2014
• Patient Sequence Number: 1
• Treatment: PATIENT BEING PREPARED FOR TRANSCATHETER AORTIC; (NOT CONTRIBUTARY).; VALVE REPLACEMENT USING RIGHT TANSFEMORAL APPROACH
• Patient Age: 81 YR
• Patient Weight: 46