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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE CLAMP, VASCULAR

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
The explanted valve has been returned for evaluation. Device evaluation anticipated, but not yet begun. A supplemental report will be submitted once the evaluation has been completed.
 
Event Description
Edwards received notification that a balloon puncture was observed while using this intraclude device model icf100. As reported the puncture was not caused by a needle puncture nor by over inflation. No leak had been observed during prepping and a standard operative procedure had been followed. Reportedly, this was the 4th redo procedure for this patient who underwent a mvr, a tvr, a maze procedure and an atrial septal defect (asd) closure. The procedure was performed with minimally invasive (mis) approach with proplege device. A new balloon was opened to finish the case.
 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
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
gail warner
1 edwards way
mailstop ant 6.1
irvine, CA 92614
9492504096
MDR Report Key11946941
MDR Text Key254876119
Report Number2015691-2021-03340
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberICF100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2021
Was Device Evaluated by Manufacturer? No
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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