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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER Back to Search Results
Model Number ICF100
Device Problem Material Rupture (1546)
Patient Problems Failure of Implant (1924); Blood Loss (2597)
Event Date 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
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, all fragments were able to be retrieved the patient was reported to be doing fine. Follow up for the device is still in progress and the investigation is pending. A supplemental report will be submitted upon receipt of additional information.
 
Event Description
It was reported that the balloon of an intra-aortic occlusion catheter ruptured during use. As reported, the patient¿s aorta size was 3. 2 and there was no a high amount of calcification. The total inflation volume was not provided. The surgical team struggled with getting complete occlusion throughout the entire case and bleeding was noticed. The balloon was not repositioned during the case. There were no sewing sutures near the balloon when the rupture occurred. The balloon pressure was maintained in the 200-250 range which was also the internal pressure prior to rupture. The duration of use prior to the balloon burst was unknown. The surgeon waited until the repair was done before adding volume to the balloon. The balloon rupture immediately after 2cc of saline was added. All fragments were able to be retrieved. The team was able to finish the case without additional clamping. The patient was reported to be doing fine.
 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
Type of DeviceINTRA-AORTIC OCCLUSION CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
mle-2
irvine, CA 92614
9492504062
MDR Report Key8808390
MDR Text Key151859787
Report Number3008500478-2019-00154
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/11/2021
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61979877
Was Device Available for Evaluation? Yes
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 Manufactured04/01/2019
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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