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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 Problems Failure to Zero (1683); Inaccurate Information (4051)
Patient Problem Cardiac Arrest (1762)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was returned to edwards for evaluation. Evaluation is in progress. Based on the information received the cause of the event cannot be determined. No further corrective or preventative actions are required at this time. Edwards lifesciences will continue to monitor all reported events.
 
Event Description
Edwards received information that during inflation of a vascular clamp, the aortic root pressure, even with root vent running, did not drop to zero or negative with expected fill volume. It dropped from approximately 65 to 25 with 30 ml of volume and an internal balloon pressure of 390 mmhg. Perfusion also was not getting any blood back to pump from vent at this point. Antegrade cardioplegia was delivered, patient had a quick arrest and retrograde cardioplegia was delivered throughout the case (approximately 50 ml as the patient had prior cabg with patent mammaries). Throughout the case, aortic root never got to zero and always stayed approximately 25 even with periodic running of aortic vent to clear retrograde cpb through coronaries. The rest of the case was uneventful.
 
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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
amritha srinivasan
1 edwards way
mle2
irvine, CA 92614
9492502289
MDR Report Key8413373
MDR Text Key139044193
Report Number3008500478-2019-00113
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,Followup,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/07/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61713209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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