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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 Burst Container or Vessel (1074); Material Rupture (1546); Pressure Problem (3012)
Patient Problem Rupture (2208)
Event Date 05/29/2019
Event Type  malfunction  
Manufacturer Narrative
The device was returned to edwards for evaluation. Evaluation is in progress. The clamp device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures. If the balloon bursts 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. A definitive root cause could not be determined at this time. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
 
Event Description
Edwards received notification that during a mini-thoracotomy mitral procedure, the balloon of an icf100 burst and surgeon had to use a chitwood clamp to complete the procedure. As reported, the balloon was not overinflated, they inflated about 50 ml. The aorta was round about 32 mm. At the time of the burst no manipulation/stitching was done near the balloon, the surgeon was working with loops on the leaflets. As reported, before the balloon burst, the pressure was lost several time and they had to add volume to maintain pressure between 300 and 350. The device was tested before use and found to be ok. At the end of the case, the patient was noted as to be fine. Surgeon is very experienced in using the product.
 
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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
12050 lone peak parkway
mle2
draper, UT 84020
9492502289
MDR Report Key8740449
MDR Text Key149631227
Report Number3008500478-2019-00145
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeGM
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 06/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/18/2021
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61898938
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
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 Manufactured02/28/2019
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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