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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 Problems Mechanical Problem (1384); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2018
Event Type  Injury  
Manufacturer Narrative
Udi # (b)(4). The devices has been returned for evaluation; however, the analysis is still in progress. A supplemental report will be submitted accordingly once the product evaluation has been completed.
 
Event Description
It was reported that during a mitral valve procedure with mini-sternotomy, the endoballoon of an icf100 floated up and unable to be oriented properly. Per the surgeon, the balloon did not seem parallel with the aorta. The surgeon felt that there may have been a fracture in the catheter. A second icf100 was opened and used and the endoballoon still could not be properly oriented. It was unsure if there was a mechanical problem with the balloon or if the patient had extenuating circumstance unknown to the surgeon. The balloon tip was not against the aorta wall. There did not appear to be any unique anatomy. The balloon was observed in the aortic root on tee. However, the balloon was advanced at the groin all the way to the hub. The patient did not experience any adverse events. The patient was reported to be doing well post procedure.
 
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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
amritha srinivasan
12050 lone peak parkway
mle-2
draper, UT 84020
9492504062
MDR Report Key8344431
MDR Text Key136303865
Report Number3008500478-2019-00106
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/15/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2019
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 Manufactured10/28/2018
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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