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Catalog Number IAB-R950-U |
Device Problems
Device Alarm System (1012); Material Rupture (1546)
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Patient Problem
Vessel Or Plaque, Device Embedded In (1204)
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Event Date 01/03/2018 |
Event Type
Injury
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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 the intra-aortic balloon (iab) was inserted in the left axilla, and the iab ruptured the same day.As a result, the iab was removed, but a surgical cut down was required.There was no report of patient death.
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Manufacturer Narrative
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(b)(4).Teleflex did not received the device for investigation therefore the reported complaint of "blood in helium pathway" 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.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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 the intra-aortic balloon (iab) was inserted in the left axilla, and the iab ruptured the same day.As a result, the iab was removed, but a surgical cut down was required.There was no report of patient death.
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Search Alerts/Recalls
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