Catalog Number 0684-00-0514 |
Device Problems
Leak/Splash (1354); Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(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.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy the balloon ruptured.There was no reported injury to the patient.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy the balloon ruptured.There was no reported injury to the patient.
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Manufacturer Narrative
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Evaluation method codes - device discarded [4115].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); record id (b)(4).
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Search Alerts/Recalls
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