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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARD INTRACLUDE INTRAAORTIC OCCLUSION DEVICE
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EDWARDS LIFESCIENCES EDWARD INTRACLUDE INTRAAORTIC OCCLUSION DEVICE Back to Search Results
Lot Number 61139242
Device Problems Hole In Material (1293); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, (b)(6) placed edwards through port intraclude intra-aortic occlusion device which acts as a cross-clamp while pt on bypass machine.The perfusionist stated he wasn't getting good pressures and something didn't seem correct.Dr (b)(6) removed the balloon and placed a new balloon and the perfusionist said there was an improvement.Dr (b)(6) examined the original device and discovered a small hole in the device.Dates of use: (b)(6) 2018.Diagnosis or reason for use: minimally invasive replacement mitral valves, mini thoracotomy."is the product compounded: no, is the product over-the-counter: no.".
 
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Brand Name
EDWARD INTRACLUDE INTRAAORTIC OCCLUSION DEVICE
Type of Device
INTRAAORTIC OCCLUSION DEVICE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
irvine CA 92614
MDR Report Key7327143
MDR Text Key102090420
Report NumberMW5075776
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2019
Device Lot Number61139242
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight71
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