Catalog Number IAB-S840C |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).For related complaint and event see mdr #3010532612-2018-00368.And tc # (b)(4).
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Event Description
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It was reported that during insertion of the intra-aortic balloon (iab) it was noted by the staff that the new balloon was defective and was difficult to pass through the wire.As a result, a new iab kit was opened and used on the patient.There was no report of patient complication or serious injury and death.
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Manufacturer Narrative
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(b)(4) for related complaint and event see mdr #3010532612-2018-00368 and (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.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.If the product is returned at a later date, a full investigation of the sample will be completed.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) it was noted by the staff that the new balloon was defective and was difficult to pass through the wire.As a result, a new iab kit was opened and used on the patient.There was no report of patient complication or serious injury and death.
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Search Alerts/Recalls
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