Catalog Number IAB-S840C |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/03/2018 |
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 the spring wire guide (swg) could not pass through the intra-aortic balloon (iab) catheter after the sheath was inserted.As a result, the catheter was exchanged for another and a second attempt was made successfully.Patient outcome reported as fine.There was no report of patient complication or serious injury and death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iab tight over guidewire is confirmed.Upon visual inspection, a kink was noted to the central lumen.Upon inserting a guidewire, resistance was experienced at the location of the kink.The root cause of the kink 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 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 the spring wire guide (swg) could not pass through the intra-aortic balloon (iab) catheter after the sheath was inserted.As a result, the catheter was exchanged for another and a second attempt was made successfully.Patient outcome reported as fine.There was no report of patient complication or serious injury and death.
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Search Alerts/Recalls
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