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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE CLAMP, VASCULAR

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. In this case, the root cause cannot be determined with the available information. It is unknown whether patient and/or procedural related factors may have caused or contributed to the event. The subject device has not been returned for evaluation; therefore, the reported event could not be confirmed. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed. If new information becomes available, a supplemental report will be submitted.
 
Event Description
Edwards received notification of 2 balloon ruptures occurred during the procedure. As reported, the balloon pressure was normal and with no extra volume. The devices were checked before use. Balloon pressure was maintained constant throughout the procedure. Surgeon has got high level of experience. No other details were provided.
 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
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
12050 lone peak parkway
mle-2
draper, UT 84020
9492504062
MDR Report Key8723211
MDR Text Key149081131
Report Number3008500478-2019-00142
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/18/2021
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61898938
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 Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2019
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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