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Model Number ICF100 |
Device Problems
Leak/Splash (1354); Decrease in Pressure (1490); Material Puncture/Hole (1504)
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Patient Problem
No Information (3190)
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Event Date 03/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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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Manufacturer Narrative
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Evaluation summary: customer report that "small hole was observed on the side of the balloon" was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.Balloon failed to maintain inflation due to a pin hole leakage.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.The root cause of this event remains indeterminable with the available information.There were no issues identified with the manufacturing, supplier or design of this product.There were also no issues with the instructions for use or labeling of the device.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference (b)(4).
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Search Alerts/Recalls
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