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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 Material Puncture/Hole (1504); Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 information received the cause of the event cannot be determined. If additional information is received a supplemental mdr will be submitted. No further corrective or preventative actions are required at this time. Edwards lifesciences will continue to monitor all reported events.
 
Event Description
Edwards received notification that during a mis-mvr surgery, there was a balloon pressure/volume loss in a clamp. This was notified and recognized as the balloon was moving in the ventricle. The migration occurred to an extent that the balloon was finally stitched with a needle and burst. The user complaint is against the balloon volume loss. It was possible to finish the procedure under ventricular fibrillation. The patient was doing fine after the surgery.
 
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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 Key8518654
MDR Text Key142375264
Report Number3008500478-2019-00123
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 03/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/26/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61713218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
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 Manufactured12/29/2018
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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