Catalog Number IAB-S840C |
Device Problems
Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/21/2018 |
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 in the cath lab an intra-aortic balloon catheter (iabc) was tried with a new balloon but unable to negotiate on sheath because balloon was kinked.As a result, a new kit was used.There was a report of delay in therapy.There was no report of patient complication or serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab kinked is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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 risks.This will be monitored for any developing trends.No further action required at this time.Other remarks: the reported complaint has been reopened to investigate the device that was returned to teleflex for investigation.The reported complaint of iab kinked is confirmed.Several kinks were noted on the returned iab's central lumen near the proximal end of the iab bladder during the complaint investigation.The root cause of how the central lumen became kinked is undetermined.A potential cause is user handling.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.The reported complaint will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that in the cath lab an intra-aortic balloon catheter (iabc) was tried with a new balloon but unable to negotiate on sheath because balloon was kinked.As a result, a new kit was used.There was a report of delay in therapy.There was no report of patient complication or serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab kinked is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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 risks.This will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that in the cath lab an intra-aortic balloon catheter (iabc) was tried with a new balloon but unable to negotiate on sheath because balloon was kinked.As a result, a new kit was used.There was a report of delay in therapy.There was no report of patient complication or serious injury or death.
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Search Alerts/Recalls
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