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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 Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2019
Event Type  malfunction  
Manufacturer Narrative
The explanted valve has been returned for evaluation. Device evaluation anticipated, but not yet begun. A supplemental report will be submitted once the evaluation has been completed.
 
Event Description
It was reported that the balloon leaked from the tip of the icf100 intraclude device. The balloon itself remained intact. It was indicated that the surgical staff tried to limp through the procedure, but had to continuously add volume, as it would not hold a seal. Therefore, the device was removed and the chitwood clamp was applied, and the case was completed. Upon removal, the balloon was inspected and found to leak out of the tip. The size of the aorta is unknown. The total inflation volume was per ifu recommendation. The balloon pressure was maintained usually around 300. It is unknown how much saline was added to maintain pressure. The amount of calcification is unknown. The patient was reported to be fine.
 
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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 Key8981857
MDR Text Key207055756
Report Number3008500478-2019-00157
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberICF100
Device Catalogue NumberICF100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2019
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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