Model Number IPN000262 |
Device Problems
Difficult to Insert (1316); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: see mdr# 3010532612-2020-00354 (tc 1900080711) as the report is related to the same patient.
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Event Description
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It was reported that the intra-aortic balloon (iab) dispersed during insertion, which made it difficult to insert.As a result, another iab was used and inserted using the same insertion site.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint iab unwrapped prematurely is confirmed.The one-way valve failed during functional testing.A failing one-way valve will result in difficulty of pulling and maintaining a vacuum on the iab bladder.If a vacuum of the bladder is not maintained, it can result in insertion difficulty.The iab bladder membrane passed functional testing.The root cause of the complaint is undetermined.A potential cause is user related due to the dried media on the valve seal.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00354 (tc 1900080711) as the report is related to the same patient.
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Event Description
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It was reported that the intra-aortic balloon (iab) dispersed during insertion, which made it difficult to insert.As a result, another iab was used and inserted using the same insertion site.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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