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Model Number IPN000263 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/09/2020 |
Event Type
malfunction
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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 after the guidewire was implanted, the staff tried to pass the intra-aortic balloon (iab) but was unsuccessful.The staff stated that the iab had a "phenomenon of kinked".As a result, a new iab was used.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that after the guidewire was implanted, the staff tried to pass the intra-aortic balloon (iab) but was unsuccessful.The staff stated that the iab had a "phenomenon of kinked".As a result, a new iab was used.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of iab kinked is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 revived risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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