Catalog Number IAB-05840-LWS |
Device Problems
Detachment Of Device Component (1104); Entrapment of Device (1212); Difficult to Remove (1528)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/21/2018 |
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 by the rn that they have a patient they brought to the cardiac cath lab (ccl) to remove an intra-aortic balloon (iab).The cardiologist was pulling the catheter out when he realized the tip had separated from the catheter and was retained in the femoral artery.They transferred the patient to the or for a surgical removal of the retained tip.The patient was hemodynamically stable and the removal of the tip was successful.Surgical removal of the tip of the iab was performed from the femoral artery.Surgery was reported successful.Patient current condition noted as fine.
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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 removal difficulty" 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.The reported complaint 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 by the rn that they have a patient they brought to the cardiac cath lab (ccl) to remove an intra-aortic balloon (iab).The cardiologist was pulling the catheter out when he realized the tip had separated from the catheter and was retained in the femoral artery.They transferred the patient to the or for a surgical removal of the retained tip.The patient was hemodynamically stable and the removal of the tip was successful.Surgical removal of the tip of the iab was performed from the femoral artery.Surgery was reported successful.Patient current condition noted as fine.
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Search Alerts/Recalls
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