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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 Problems Deflation Problem (1149); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures. Changes in vascular tone may result in variations of balloon occlusion pressure. It is not unusual for the surgical teams to have to add volume during the case to ensure occlusion. If this routine trouble shooting is unsuccessful and a change in operative strategy (the placement of an external cross clamp, having to exchange the device after bypass is initiated) is required, this event will be reportable. In this case, the balloon was deflated and the occlusion was lost. The device was required to be exchanged. The device evaluation is anticipated, but not yet begun. The device history record (dhr) review is in progress. A supplemental report will be submitted upon evaluation and dhr completion.
 
Event Description
It was reported that the balloon of a intra-aortic occlusion catheter was deflated and the occlusion was lost within 1-2 minutes. Intraclude was placed in patient aorta via echo. The device was replaced with a new intra-aortic occlusion catheter and used without difficulty. No patient injury was noted. As reported, no leak or accidental puncture to the balloon was noticed.
 
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Brand NameINTRACLUDE
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 Key8143943
MDR Text Key130185366
Report Number3008500478-2018-00095
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 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/26/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61531655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
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 Manufactured10/15/2018
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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