Catalog Number 0684-00-0567 |
Device Problems
Unraveled Material (1664); Malposition of Device (2616)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy that the iab unwrapped prior to insertion and seemed to jump in the aorta during inflation.The indication for use is left main disease 99%.There was no reported injury to the patient.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy that the iab unwrapped prior to insertion and seemed to jump in the aorta during inflation.The indication for use is left main disease 99%.There was no reported injury to the patient.
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Manufacturer Narrative
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No decontamination or visual inspection of product was performed since it was not returned.A video was provided for this event which shows the iab movement.A review of the video confirms the reported iab migration/movement.A visual review of the video is unable to confirm difficulty during insertion of the iab.The product was not returned and so could not be evaluated for root cause.A review of the provided video confirms the iab migration event, but we are unable to confirm the difficulty during insertion of the iab based on the provided video.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).
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Search Alerts/Recalls
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