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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE CLAMP, VASCULAR

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EDWARDS LIFESCIENCES INTRACLUDE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Inflation Problem (1310)
Patient Problem No Information (3190)
Event Date 07/25/2017
Event Type  Injury  
Manufacturer Narrative
Additional manufacturer narrative: edwards received additional information through follow-up with the health care provider. Per the surgeon, the balloon did not cause any issues with the patient and there was no hole in the balloon upon inspection after removal. The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution. No issues were identified that would have impacted this event.
 
Manufacturer Narrative
Additional manufacturer narrative: the device was not returned to edwards for evaluation. The clinical observation was unable to be confirmed. The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures. If the intraclude balloon is not totally occlusive during a procedure, the heart would fill and warm, the operative site may be obscured and the procedure may need to convert to an open procedure. In this case, the intraclude was removed and a cross clamp was used. A definitive root cause could not be determined. No further corrective or preventative actions are required at this time. Edwards will continue to review and monitor all events through the use of edwards quality systems. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
 
Event Description
It was reported that the balloon pressure dropped and a small bubble in the balloon pressure line was observed when the surgeon was using an intra-aortic occlusion catheter during antegrade cardioplegia delivery. After the bubble was evacuated by using a syringe, the pressure was 34mmhg and the surgeon decided to use a traditional cross lamp as to not slow down the procedure. No other information was provided. Patient outcome was reported to be no injury.
 
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Brand NameINTRACLUDE
Type of DeviceCLAMP, VASCULAR
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
lfs-33
irvine, CA 92614
9492502289
MDR Report Key6798460
MDR Text Key109782152
Report Number3008500478-2017-00041
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/12/2016
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number60596261
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/16/2017 Patient Sequence Number: 1
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