Catalog Number 0684-00-0549-01 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Complete event site name: (b)(6).Event site postal code: (b)(6).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.Complaint record id # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the iab could not be used due to a kink.There was no patient harm or adverse event reported.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the iab could not be used due to a kink.There was no patient harm or adverse event reported.
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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.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.Reference complaint # (b)(4).
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Search Alerts/Recalls
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