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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CARPENTIER-EDWARDS MITRAL ANNULOPLASTY RING SIZER SIZER, HEART-VALVE, PROSTHESIS Back to Search Results
Model Number 1150
Device Problem Fracture
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.

 
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Brand NameCARPENTIER-EDWARDS MITRAL ANNULOPLASTY RING SIZER
Type of DeviceSIZER, 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 Key5629070
Report Number2015691-2016-01464
Device Sequence Number1
Product CodeDTI
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1150
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/05/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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