MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS REUSABLE HANDLE; RING, ANNULOPLASTY

Model Number 1150

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

The product is expected for return; however, it has not been returned at this time.The reported event cannot be confirmed with the available information.The device's instructions for use (ifu) caution the user to: examine handles for signs of wear, such as dullness, cracking or crazing.Replace handle if any deterioration is observed.Edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required based on the determined control limits, appropriate investigation will be performed.If any new information is received or if the device is returned, a supplemental report will be submitted accordingly.

Event Description

Edwards received information that a plastic fragment of handle for an edwards physio ii ring was found in the operative field.Per reported information, the handle was attached to the ring holder in the outside of operative field.After sliding the ring down, a thread on the ring holder was cut, and the handle and the ring holder were returned to the outside of operative field.The surgeon did not realize that the tip of handle was broken at this moment; however, another surgeon found a plastic fragment in the operative field ant it was a part of the tip of handle.

Manufacturer Narrative

Customer report of ring handle broken was confirmed.As received, part of the connection point of the handle was broken.The returned fragment measured 5mm x 3mm, and matched up to the handle.

Manufacturer Narrative

Through further analysis of this event, it has been determined that it is likely the tab broke during attachment of the device to the handle, or during handle bending to adjust the orientation of the device for implantation.In addition, this handle was manufactured prior to 2012, and the customer stated that it had been used for four (4) or five (5) years.There are no indications that the handle broke due to a manufacturing defect.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

• Brand Name: EDWARDS REUSABLE HANDLE
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7127470
• MDR Text Key: 95808810
• Report Number: 2015691-2017-04351
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1