Catalog Number 0684-00-0475 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/24/2019 |
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 during intra-aortic balloon (iab) therapy, resistance was felt trying to advance the balloon over the guide wire into the patient.The balloon was replaced.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.Complaint record # (b)(4).
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Event Description
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It was reported during intra-aortic balloon (iab) therapy, resistance was felt trying to advance the balloon over the guide wire into the patient.The balloon was replaced.There was no reported injury to the patient.
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Search Alerts/Recalls
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