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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE CLAMP, VASCULAR

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EDWARDS LIFESCIENCES INTRACLUDE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Aortic Dissection (2491)
Event Date 04/02/2018
Event Type  Injury  
Manufacturer Narrative
The device was not returned to edwards for evaluation. An aortic dissection is a tear in the inner lining of the aorta. As a result, blood flows through this newly created false channel, which raises a flap that can occlude blood flow in the true lumen. This can result, in extreme cases, in occlusion of blood flow to the coronary, carotid, or subclavian arteries, and can result in hemodynamic instability and/or death without surgical intervention. A definitive root cause could not be determined. As there has been no confirmed design defect, manufacturing issue, or inadequacy in the labeling, ifu, or training leading to the complaint, edwards will continue to review of all reported events and perform trend analysis on a monthly basis. If action is required based on the determined control limits, appropriate investigation will be performed. No corrective or preventative actions are required at this time.
 
Event Description
It was reported that a dissection of the ascending aorta was found in a patient using an icf100. Upon going on bypass for a mitral valve procedure, the balloon of the icf100 was inflated and arterial pressure from the right art line dropped to approximately 30mmhg. Despite repositioning, the right art line reading never improved. After the mitral valve replacement concluded and the balloon was removed the art line reading remained at approximately 30mmhg. The patient came off bypass fine but a dissection of the ascending aorta was found. The surgeon did not indicate that the patient had any pre-existing conditions that may have contributed to the dissection. No additional intervention was necessary to treat the dissection found at the ascending aorta. Through follow-up it was learned that the pressure reading was able to be taken initially. Troubleshooting done included flushing lines, using cerebral monitoring, and checking all stopcocks. No kinks were noticed along the red line. There was no tip damage noted.
 
Manufacturer Narrative
Additional manufacturer narrative: manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.
 
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Brand NameINTRACLUDE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
neil landry
1 edwards way
lfs-33
9492502289
MDR Report Key7451220
MDR Text Key106188061
Report Number3008500478-2018-00063
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/24/2019
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61097633
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2017
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: 04/23/2018 Patient Sequence Number: 1
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