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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 Leak/Splash (1354); Decrease in Pressure (1490); Material Puncture/Hole (1504)
Patient Problem No Information (3190)
Event Date 03/27/2019
Event Type  malfunction  
Manufacturer Narrative
The subject device 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
It was reported that during a mini mitral repair, the icf100 intraclude device had started to lose pressure towards the end of the case. The decision was made to not cross-clamp and the heart was allowed to fibrillate until completion. Post procedure the balloon was checked and a small hole was observed on the side of the balloon. The patient was reported to be stable and doing well. Additional information received indicated that the nurse scrub confirmed there was no leak visible when she prepared it. The nurse had to add volume to the balloon throughout the duration of the case. She could not tell how much. They routinely kept the balloon at 20cc's, no more. The surgeon shared that at 20cc's, they could not see a leak in the balloon, as the nurse preps routinely, but after the case they did see a leak after putting 25cc's of fluid in the balloon.
 
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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 Key8527779
MDR Text Key142884864
Report Number3008500478-2019-00124
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 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/25/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61713205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2019
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 Manufactured11/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/18/2019 Patient Sequence Number: 1
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