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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 Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 09/09/2020
Event Type  Injury  
Manufacturer Narrative
The device was returned to edwards for evaluation. Evaluation is in progress. 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. A definitive root cause could not be determined at this time. A supplemental mdr will be submitted upon completion of device evaluation. Edwards lifesciences will continue to monitor all reported events.
 
Event Description
Edwards received notification that during use of this ifc100 a hole was observed on the balloon. The device was used for a mitral valve repair. Reportedly, patient had good iliac vessels, but the aorta was very calcified. As reported, during preparation everything was ok. There was no problem with the balloon, and no hole was observed. When the surgeon wanted to occlude the heart he stopped a few minutes because of the adenosine in the cardioplegia. There was no blood pressure drop. The surgeon added 35+5cc in the balloon. The heart did not stop so the surgeon added more volume, with no success. As per the surgeon opinion it was a pressure issue, as there was no needle around the balloon. It was therefore decided to removed the intraclude device and upon examination it was observed that there was a small hole centrally located in the balloon, less than 1mm aprox. No blood was observed inside the balloon.
 
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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
amritha srinivasan
1 edwards way
irvine, CA 92614
9492504062
MDR Report Key10621998
MDR Text Key214643309
Report Number3008500478-2020-00207
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K163693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number63202471
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/02/2020 Patient Sequence Number: 1
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