Model Number IPN000263 |
Device Problems
Break (1069); Difficult to Insert (1316)
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Patient Problems
No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
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Event Date 11/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the intra-aortic balloon (iab) tip was found cracked during insertion on the patient's right femoral artery, which cause insertion difficulty.As a result, a new iab kit was used to complete treatment at a new insertion site on the patient.There was no report of patient complications or death.
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Event Description
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It was reported that the intra-aortic balloon (iab) tip was found cracked during insertion on the patient's right femoral artery, which cause insertion difficulty.As a result, a new iab kit was used to complete treatment at a new insertion site on the patient.There was no report of patient complications or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint iab insertion difficulty 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 iab insertion difficulty.The iab bladder membrane passed dimensional and functional inspection.The root cause of the failing one-way valve is undetermined.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.A supplier corrective action request (scar) has been previously opened for one-way valve failures upon manufacturing assembly testing; however, this failure was noted with dried blood/debris inside the one-way valve.This will be monitored for any developing trends.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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