MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PERIMOUNT MAGNA EASE SIZER; SIZER, HEART-VALVE, PROSTHESIS

Model Number 1133

Device Problems Break (1069); Material Discolored (1170)

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

Event Date 02/04/2014

Event Type  malfunction  

Event Description

As reported, the metal handle of the sizer was detached from the cylindrical end while attempting to size the patient¿s annulus.It was reported that upon inspection of the sizer head, a small piece was missing on the inside lip of the sizer, close to the attachment point of the handle.The missing piece was not located.The sizer was not inspected prior to use.Based on our follow-up, it was learned that the sizer was in the hospital for more than three (3) years and has been sterilized approximately 100 times using gigasept af and steam under 134 degrees for 5 minutes.There were no adverse patient effects reported as a result of the reported event.The subject device has been discarded in the hospital.No other details reported.

Manufacturer Narrative

The subject device is no longer available for evaluation as it was discarded at the hospital.Therefore, we are unable to confirm the event and to determine root cause for the reported event.Per the product instructions for use (ifu) list time and temperature guidelines as well as equipment and solution recommendations for by hand and by machine cleaning and sterilization.Included in the ifu is the following statement: "caution: examine sizers and handles for signs of wear, such as dullness, cracking or crazing.Replace sizer/handle if any deterioration is observed." it is assumed this event occurred because the device was not examined and inspected as recommended by the ifu.

• Brand Name: PERIMOUNT MAGNA EASE SIZER
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 3661611
• MDR Text Key: 4282870
• Report Number: 2015691-2014-00523
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1133
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/05/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1