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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 Rupture (1546)
Patient Problem Ventricular Fibrillation (2130)
Event Date 04/09/2019
Event Type  malfunction  
Manufacturer Narrative
The device was returned to edwards for evaluation. Evaluation is in progress. The clamp device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures. If the balloon bursts 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 cannot be determined at this time. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
 
Event Description
Edwards received notification that balloon rupture of this clamp occurred during a minimally invasive mitral valve replacement with a non-edwards device. As reported, the customer had tested the device outside the patient's body before use and no issue was observed. The rupture occurred while the surgeon was checking the mitral valve, far from sharp instruments and from the balloon. As per the surgeon, the rupture was not caused by surgical manipulations, neither was the balloon over-inflated or used in other way than prescribed in the ifus. The surgeon managed to complete the procedure with the patient under ventricular fibrillation. After the procedure, the patient was transferred to the icu and was noted as to be fine.
 
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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 92614
9492502289
MDR Report Key8574724
MDR Text Key144147681
Report Number3008500478-2019-00131
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K163693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/05/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61723505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2019
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
Date Device Manufactured01/01/2019
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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