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

Model Number 1150

Device Problem Fracture (1260)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: as received, the connection point of handle was broken off; broken piece was not returned.The root cause of the holder breaking could not be conclusively determined.It is unknown how many sterilization cycles the complaint device had gone through before it broke, and how much force had been applied during each use.Customer report of cracked handle was confirmed.Handles or sizers that fragment when in use within the operative field have the potential to result in a piece being retained in the heart that could then embolize when the patient¿s heart begins beating.This has the potential to cause a stroke or myocardial infarction.In this case, there was no impact to the patient.Based on the evaluation, the root cause cannot be determined for this event because the number of times this device was used and sterilized remains unknown.Ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications.The ifu states, "handles should be examined for signs of wear, such as dullness, cracking, or crazing and should be replaced immediately if any deterioration is observed.Accessories should be replaced on a routine basis." based on the available information, no corrective action will be taken as this event does not appear to be manufacturing related.No further action will be taken at this time as the handles were likely cracked or bent due to the age of the device and number of sterilization cycles performed.

Event Description

Edwards received information that the tip of the handle for an annuloplasty ring was cracked.Reportedly, the nurse attached the first handle to the ring holder and handed the device to the lead surgeon during a mitral annuloplasty case.The handle was not attached to the ring holder completely; the lead surgeon attached the handle to the ring holder completely.Right before the lead surgeon was making guide marks for sutures on the ring, the ring popped off and hit the face (unsterile field) of the other doctor landing in the sterile field.It was confirmed that tip of the handle was bent and cracked.Patient was reported doing well after surgery.It was reported that cleaning of this device was performed using a jet washer at 70 degrees celsius for 10 minutes with an alkaline detergent.Disinfectant used was an neutral-enzyme detergent.Sterilization method used 135 degrees celsius of negative pressure for 15 minutes via autoclave sterilization and double packaging.The customer did not know how many sterilization cycles these handles went through.The handle was returned for evaluation.

• Brand Name: CARPENTIER-EDWARDS MITRAL ANNULOPLASTY RING 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 ; one edwards way; mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5629070
• MDR Text Key: 44344403
• Report Number: 2015691-2016-01464
• Device Sequence Number: 1
• Product Code: DTI
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• 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: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1