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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER Back to Search Results
Model Number ICF100
Event Date 03/15/2019
Event Type  Death  
Manufacturer Narrative

Evaluation summary: the device was returned with visible traces of blood and was examined in the biohazard area of the lab. As received, the balloon was observed to be ruptured. Edges of rupture site appeared to match up. All through lumens were found to be patent without any leakage or occlusion. No other visual damage, contamination, or other abnormalities were found. Engineering task has been opened and assigned for further investigation. Additional manufacturer narrative: 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. In this case, the balloon ruptured and possibly lead to a prolonged or time. The device was evaluated and the report of "balloon burst" was confirmed. An engineering evaluation has been opened for further investigation. A supplemental report will be submitted upon completion.

 
Event Description

Edwards received notification that during a totally endoscopic coronary artery bypass (tecab) surgery using an intra-aortic occlusion catheter device, there was a balloon burst. The medical team is very experience with the use of the device (approx. 38 cases in tecab with intra-aortic occlusion catheter ). As reported, the balloon bursted during the anastomosis of the vessel lima to riva so there was no possibility to accidentally stitched the balloon in the aorta during that process. The team was able to remove the ruptured intra-aortic occlusion catheter device and replace it with a second one so they was able to finish the operation. The patient died approximately 10 days after surgery with the estimated diagnosis of hypoxic brain damage. As reported it was no clear if the prolonged or time/balloon burst is responsible for this event. As per perfusion report, the total cpb time was 4 hours 50 min and aorta clamp time was 2 hours 6min.

 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
Type of DeviceINTRA-AORTIC OCCLUSION CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
mle-2
irvine , CA 92614
9492504062
MDR Report Key8556944
Report Number3008500478-2019-00128
Device Sequence Number1
Product CodeDXC
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 04/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2019
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberICF100
Device Catalogue NumberICF100
Device LOT Number61713218
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/26/2019 Patient Sequence Number: 1
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