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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES INTRA-AORTIC OCCLUSION DEVICE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Material Puncture/Hole (1504)
Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  Injury  
Manufacturer Narrative
Additional narratives 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 device was returned and product evaluation is ongoing. If new information becomes available, a supplemental report will be submitted.
 
Event Description
Edwards received notification that a tiny hole was observed on the balloon of this catheter used for the clamping of the aorta during a mitral valve repair & surgery for atrial fibrillation treatment (maze). As reported, initial inflation pressure was 400 mmhg but the balloon started to deflate slowly losing pressure. Initially, 25-30 cm3 of sterile physiologic solution was injected into the balloon, however a few (approximate 5 cm3) had to be re-injected at least 2-3 times due to the loss of pressure. 15-20 min after initial inflation, it was decided to remove the balloon due to the constant loss of pressure. A second catheter was used in replacement. Per medical opinion, the hole was not caused by a needle puncture because the loss of pressure started before the suture placement. The suture was placed around the annulus but not in the left trigone area. The systemic/perfusion pressures were maintained at 70 mmhg during bypass and the patient's temperature was maintained at 34c. There was no any peripheral vascular disease. The patient did not suffer any injury/adverse event due to the reported event and was doing well after the procedure. As reported, no deficiencies were observed by the medical team in the packaging or in the device prior use. The priming of the balloon and the placement/positioning went as normal, following standard procedures. The patient's aorta diameter at the location of the balloon was 30mm and it was not calcified.
 
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Brand NameINTRA-AORTIC OCCLUSION DEVICE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
one edwards way
mle-2
irvine, CA 92614
9492504062
MDR Report Key11828457
MDR Text Key252423405
Report Number2015691-2021-02990
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberICF100
Device Catalogue NumberICF100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2021
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: 05/14/2021 Patient Sequence Number: 1
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