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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2019
Event Type  malfunction  
Manufacturer Narrative
Udi (b)(4). 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. Based on the available information, a definitive root cause could not be determined. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
 
Event Description
It was reported during a minimally invasive mitral valve replacement procedure with an icf 100 balloon, the balloon ruptured. A new icf 100 balloon was prepped and the procedure continued without incident. No patient injury reported and the patient was reported to be doing well post procedure. The balloon was inflated with the edwards syringe provided and the inflation volume was reported to be 40cc's. Aorta size was 4. 0cm with no notable calcification. The reported pressure throughout the case was 300-325mmhg. Balloon integrity was lost nearing the end of the annular suture placement (last one or two, in the p3 section of the mitral valve (furthest from the balloon), prior to the seating of the annuloplasty ring). The surgeon was not placing a stitch when the balloon burst, the anterolateral portion of the annulus had already been sutured, the surgeon¿s impression was that there were no sutures placed ¿deeply. ¿ the original placement of the balloon was ~2cm distal to the sinotubular junction. It was reported 2ml of saline were added about 25 min before the balloon ruptured under suspicion that it had moved to a wider portion of the ascending aorta, the internal balloon pressure was about 275mmhg, then 325mmhg after the addition. It was noted that the patient¿s aorta was larger than average prior to the incision. However, there was no ectasia noted in the ascending aorta, and the overall caliber was thought to be normal for the patient¿s habitus. Additionally, the aortic valve was grossly competent, and no signs of dilatation were present.
 
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Brand NameINTRACLUDE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
irvine
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
12050 lone peak parkway
mle2
irvine, CA 92614
9492502289
MDR Report Key8740386
MDR Text Key149651409
Report Number3008500478-2019-00144
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
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 Date03/10/2021
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61979873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2019
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 Manufactured03/27/2019
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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