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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 Puncture/Hole (1504)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  Injury  
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. If the intraclude balloon is not totally occlusive 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. The product evaluation is ongoing. If new information becomes available, a supplemental report will be submitted.
 
Event Description
It was reported that the balloon of an intra-aortic occlusion device had a pinhole leak. The issue was noted during the procedure and a second device was used to finish the case. There was no patient injury. As reported, the device was prepared per the ifu. No abnormality was noted during preparation. There was no resistance noted during insertion, advancement, or re-positioning the device. The balloon started to leak at the beginning of mitral repair case (non-robotic). There was loss of balloon volume in a slow manner. No additional volume was added because the device was replaced. There was no patient factors that could have contributed to the balloon leakage. The operator is experienced with the device.
 
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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
one edwards way
irvine CA 92614
Manufacturer Contact
gail warner
one edwards way
mailstop 6.1 anton
irvine, CA 92614
9492504096
MDR Report Key11986131
MDR Text Key256243339
Report Number2015691-2021-03537
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number63568098
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2021 Patient Sequence Number: 1
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