Catalog Number IAB-05840-LWS |
Device Problem
Failure to Zero (1683)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that the fiber optic could not analyze the pressures.As a result, the intra-aortic balloon (iab) was removed from the patient after they inserted the swg first through the distal lumen and another arrow iab-05830-lws was inserted over wire using the same sheath.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).The product was not returned for investigation.The reported complaint of iab unable to get fos signal is not able to be confirmed.The root cause of the complaint 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the fiber optic could not analyze the pressures.As a result, the intra-aortic balloon (iab) was removed from the patient after they inserted the swg first through the distal lumen and another arrow iab-05830-lws was inserted over wire using the same sheath.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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