Catalog Number 0684-00-0575 |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter name: (b)(6).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.Complaint record id # (b)(4).
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Event Description
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It was reported during insertion of the intra-aortic balloon (iab), the balloon unfurled during insertion.There was no reported injury to the patient.
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Event Description
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It was reported during insertion of the intra-aortic balloon(iab), the balloon unfurled during insertion.There was no reported injury to the patient.
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Manufacturer Narrative
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Product available for eval from: yes to: no (udi) # (b)(4).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.(b)(4).
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Search Alerts/Recalls
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