Catalog Number 0684-00-0605 |
Device Problems
Difficult to Insert (1316); Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/19/2019 |
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 insertion of the intra-aortic balloon (iab) in an emergency case, the balloon was unable to be inserted due to the membrane becoming loose.
The iab was removed and intra-aortic balloon (iab) therapy was discontinued.
There was no reported injury to the patient.
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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
|
It was reported that during insertion of the intra-aortic balloon (iab) in an emergency case, the balloon was unable to be inserted due to the membrane becoming loose.
The iab was removed and intra-aortic balloon (iab) therapy was discontinued.
There was no reported injury to the patient.
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Search Alerts/Recalls
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