Catalog Number 0684-00-0549-03 |
Device Problems
Failure to Advance (2524); Material Deformation (2976); Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, iab balloon membrane became unfurled and iab was difficult to advance through the sheath.Customer mentioned that they used the supplied introducer sheath.It was noted that the sheath tip was bent inward.Intra-aortic balloon (iab) was removed and patient was shifted on percutaneous cardiopulmonary support (pcps).There was no reported injury to the patient.
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Search Alerts/Recalls
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