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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 Problems Material Deformation (2976); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2019
Event Type  malfunction  
Manufacturer Narrative
The device was returned to edwards for evaluation. Evaluation is in progress. As reported while positioning the intraclude device, the atrial wall retractor was lifted and displaced the balloon. The intraclude device was exchanged for an external cross clamp. A definitive root cause cannot be determined. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
 
Event Description
Edwards received notification that the balloon of this clamp device was observed to be deformed. The event occurred during a mitral repair surgery done with mis approach. As reported, upon positioning of the device, the atrial wall retractor was lifted which displaced the balloon. The surgical team was not able to have a proper placement and the lv got flooded. It was decided to switch to a chitwood clamp. Upon removal of the catheter, it was tried to inflate the balloon outside of the patient body and it was noticed that the balloon was abnormally severely eccentric, which was not that deformed at first when they tested the balloon in the prepping steps. Patient outcome was noted to be good. As observed by the surgeon, the patient had a particular geometry of the ascending aorta.
 
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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
mle2
irvine, CA 84020
9492502289
MDR Report Key8487556
MDR Text Key141358524
Report Number3008500478-2019-00118
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61704656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
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

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