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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
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Insufficient Information (3190); Physical Resistance/Sticking (4012)
Patient Problem Blood Loss (2597)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
The intraclude is typically used in minimally invasive mitral valve surgery. Its purpose is to: occlude the aorta, keeping the operative field dry, particularly in patients with aortic insufficiency, deliver antegrade cardioplegia, and vent the heart. In a worst case scenario, a leak in the device could result in blood loss. If the leak is significant enough and it requires an exchange of the device after the aortic occlusion or ¿crossclamp¿ is initiated, it results in a change of operative strategy or results in hemodynamic instability requiring blood transfusion. In this case operative strategy was changed to mechanical cross-clamp. The device was not returned for evaluation, as it was reported to be unavailable. Based on the available information, the root cause of the event remains indeterminable. However, it is likely that procedural factors contributed to the event. The device history record (dhr) review is in progress, a supplemental report will be submitted upon completion.
 
Event Description
It was reported that blood was noticed when surgeon pulled volume from balloon into the syringe during a procedure of mitral valve replacement (thoracotomy) using an intra-aortic occlusion catheter. A mechanical cross-clamp was used and no patient inquiry was noted. As reported, when blowing up the balloon to occlude aorta and arrest the heart, the surgeon pulled volume from balloon into the syringe in order to re-position the balloon for optimal placement. Surgeon mentioned that it might have happened when the balloon was initially passed through the "tuohy-borst valve" on the arterial return cannula. The surgeon noted (in hindsight) that it felt tighter than normal when passing through the side arm. Prior to use the balloon was filled with about 20ml saline and the device was prepared without incidents. When deflating the device to remove so a cross clamp could be used, the pa at the table encountered resistance at the tip of the intra-aortic occlusion catheter and pulled back with a little force and sheared the balloon in half as not all volume was removed prior to removing.
 
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Brand NameINTRACLUDE
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 Key8181933
MDR Text Key131321770
Report Number3008500478-2018-00097
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/06/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61425734
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 Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2018
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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