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 11/27/2018 |
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 during insertion of the intra-aortic balloon (iab) the spring wire guide (swg) would not go easily.It was also reported that the wire got stuck during removal.As a result, the iab was removed with the sheath and another attempt was made with a new iab kit successfully.It was reported that the patient was fine.There was no report of patient complication, 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 tight over guidewire 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.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 during insertion of the intra-aortic balloon (iab) the spring wire guide (swg) would not go easily.It was also reported that the wire got stuck during removal.As a result, the iab was removed with the sheath and another attempt was made with a new iab kit successfully.It was reported that the patient was fine.There was no report of patient complication, serious injury or death.
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Search Alerts/Recalls
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