Model Number ICF100 |
Device Problems
Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Decrease in Pressure (1490); Pressure Problem (3012); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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As reported, during use, the balloon started to migrate towards the aortic valve.The balloon was repositioned and it continued to migrate towards the aortic valve.During the second dose of cardioplegia, the balloon migrated into the aortic root.In order to reposition the balloon, the surgeon removed volume from the balloon and observed blood.The surgeon was unable to re-deliver cardioplegia due to unknown reasons.Based on the information reported there was no damage to the aortic valve leaflets or myocardial ischemia but there is a potential for serious injury and/or a change in operative strategy.The device has not bee returned for evaluation and the device history record (dhr) review is pending.The root cause for the event remains indeterminable at this time.A supplemental report will be submitted upon receiving new information.
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Event Description
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Edwards received notification that issues were experienced during the use of an intra-aortic occlusion catheter device model.As reported, the placement of balloon inflation was done as per normal and without any issues.The balloon was tested before used by prepping the intra-aortic occlusion catheter before the procedure and no leak was found in the balloon.First dose of cardioplegia was given with no issues.After a while, the balloon started to migrate towards the aortic valve.The surgeon had to re-position the device for few times because the balloon would keep on migrating towards the aortic valve.When it was the time to deliver the 2nd dose of cardioplegia, the surgeon saw that the balloon was in the aortic root, therefore he had to re-position the balloon prior to the cardioplegia delivery.As he tried to re-position the balloon, he had to take some volume out of the balloon but blood was observed coming out of the lumen of the balloon (meaning that there was a communication between the internal lumens and leaks somewhere).In addition, when the surgeon tried to give the cardioplegia, it did not work as he was not able to deliver the cardioplegia.Procedure continued with the same device, cardioplegia was delivered by propledge retrograde instead of antegrade via the intra-aortic occlusion catheter , extra volume was given to keep the balloon occlusive and stable.As reported, the balloon lost pressure during the procedure which resulted in less occlusive balloon and constant balloon migration, perfusionist added volume several times.That resulted in blood entering in the operating field and coronaries, and heart activity restarted.The patient was noted as to be well.The balloon was returned for evaluation.
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Manufacturer Narrative
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The customer report of balloon issue was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.The intraclude balloon would not maintain any inflation at all due to interlumen leakage between the balloon inflation lumen and the ao root infusion lumen.Interlumen leakage was found to occur within the catheter shaft approximately 1" distal from the intraclude hub.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage or other abnormalities were found.H10: additional manufacturer narrative: the device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Based on the product and engineering evaluation, a supplier manufacturing defect was confirmed.Ifu, and labeling defect not confirmed.An edwards manufacturing non-conformance was not identified.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The investigation into the root cause is on-going as part of the corrective and preventative action.
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Manufacturer Narrative
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A supplemental report was submitted to correct the root cause analysis.Per the supplier investigation, it was concluded that the root cause of this failure was due to the core wire being pulled out of the hub.There is no indication that the product had technical issues due to the manufacturing process, no root cause of the failure could be determined.
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Manufacturer Narrative
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Reference capa-20-00141.
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Search Alerts/Recalls
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