Model Number IPN000262 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/14/2020 |
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 the intra-aortic balloon (iab) was found leaking during implantation and could not be open.As a result, a new iab was used to complete treatment.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint that the "balloon was found leaking during imp lantation" 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 revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon (iab) was found leaking during implantation and could not be open.As a result, a new iab was used to complete treatment.There was no report of delay in therapy.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 the intra-aortic balloon (iab) was found leaking during implantation and could not be open.As a result, a new iab was used to complete treatment.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).The reported complaint that the "balloon was found leaking during implantation" is not able to be confirmed.The iab catheter in question was discarded and not available for the investigation.The other insertion components returned for investigation passed specifications.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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Search Alerts/Recalls
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