Catalog Number 0684-00-0549-01 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(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 insertion of the intra-aortic balloon (iab) the sheath could not be inserted.The customer used a sheath from a different insertion kit to continue therapy.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.If provided we will send a supplemental report with our additional findings.Reference complaint # (b)(4).H3 other text: device not returned.
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Event Description
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It was reported that during insertion of the intra-aortic balloon (iab) the sheath could not be inserted.The customer used a sheath from a different insertion kit to continue therapy.There was no patient harm or adverse event reported.
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Search Alerts/Recalls
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