MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER; SIZER, HEART-VALVE, PROSTHESIS

Model Number 1133

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2014

Event Type  malfunction  

• Brand Name: EDWARDS CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 4758416
• Report Number: 4758416
• Device Sequence Number: 1
• Product Code: DTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 1133
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1