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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE VASCULAR CLAMP Back to Search Results
Model Number ICF100
Device Problem Fluid Leak (1250)
Patient Problem Ventricular Fibrillation (2130)
Event Date 12/08/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to edwards for evaluation. Attempts to retrieve the device is in process. 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 cause of the event cannot be determined at this time. A supplemental mdr will be submitted when new information and/or upon completion of the investigation. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
 
Event Description
Edwards received notification that during a robotic mitral + tricuspid valve repair surgery, issues were experienced during use of this intraclude device model icf100. A hole was observed on the cannula. As reported, the issue in the balloon lumen was detected at 45 min after balloon inflation. At that point the surgeon was implanting the annuloplasty ring, 2/3 of the ring were already attached when loss of pressure and lv filling were noticed by the surgeon. Reportedly, an attempt to re-inflate the balloon with additional volume of saline was performed but the balloon started loosing pressure again and occlusion was no longer achieved. The catheter was removed from the endo return cannula and upon inflation surgeon noted a tiny hole between the the low-flow marker and the balloon. As reported, this area of the catheter was in the arch and the surgeon was not working in that area when the issue was observed. The procedure ended under fibrillation arrest. The patient did not suffer any injury/adverse event due to this issue and was noted as to be doing well and discharged. As reported, the intraclude device and its packaging were visually examined prior use and no issues were observed. The hole was not observed during priming of the device but medical team was unsure if this kind of small defect could have been detected during priming. Reportedly, upon insertion of the catheter in the endo return cannula no resistance was noticed and the patient did not have vessels calcification.
 
Manufacturer Narrative
The device has not been returned to edwards for evaluation. Attempts to retrieve the device is in process. 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 cause of the event cannot be determined at this time. A supplemental mdr will be submitted when new information and/or upon completion of the investigation. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
 
Event Description
Edwards received notification that during a robotic mitral + tricuspid valve repair surgery, issues were experienced during use of this intraclude device model icf100. A hole was observed on the cannula. As reported, the issue in the balloon lumen was detected at 45 min after balloon inflation. At that point the surgeon was implanting the annuloplasty ring, 2/3 of the ring were already attached when loss of pressure and lv filling were noticed by the surgeon. Reportedly, an attempt to re-inflate the balloon with additional volume of saline was performed but the balloon started loosing pressure again and occlusion was no longer achieved. The catheter was removed from the endo return cannula and upon inflation surgeon noted a tiny hole between the low-flow marker and the balloon. As reported, this area of the catheter was in the arch and the surgeon was not working in that area when the issue was observed. The procedure ended under fibrillation arrest. The patient did not suffer any injury/adverse event due to this issue and was noted as to be doing well and discharged. As reported, the intraclude device and its packaging were visually examined prior use and no issues were observed. The hole was not observed during priming of the device but medical team was unsure if this kind of small defect could have been detected during priming. Reportedly, upon insertion of the catheter in the endo return cannula no resistance was noticed and the patient did not have vessels calcification.
 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Type of DeviceVASCULAR CLAMP
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
reginald santos
1 edwards way
irvine, CA 92614
9492502731
MDR Report Key13061485
MDR Text Key285613258
Report Number2015691-2021-06976
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberICF100
Device Lot Number63568099
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2020
Is the Device Single Use? Yes

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