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 06/06/2018 |
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 intra-aortic balloon (iab) catheter couldn't be advanced through the sheath.As a result, a new kit was used and successfully inserted.Patient outcome reported as fine.There was no report of patient complication, serious injury or death.
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Event Description
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It was reported that the intra-aortic balloon (iab) catheter couldn't be advanced through the sheath.As a result, a new kit was used and successfully inserted.Patient outcome reported as 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 received the device for investigation.The reported complaint that there was a leak at the hub of the central lumen is confirmed.During functional testing, a crack was found at the injection site of the bifurcate for the central lumen.This crack allowed a leak to occur at the injection site of the central lumen.Therefore, the root cause of how the crack occurred 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.However, the received product did not meet specifications during the complaint investigation due to the crack found on the bifurcate.A nonconformance has been initiated to investigate the root cause.The reported complaint will be monitored for any developing trends.
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Manufacturer Narrative
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(b)(4).This follow up report #2 is being resubmitted to you because the information contained in the previous follow up #1 report that was submitted to you included inaccurate information.Please find the updated, corrected "additional manufacturer narrative" in this report.Teleflex received the device for investigation.The reported complaint of iab could not advance in sheath is confirmed.The central lumen was found kinked, which blocked the guidewire from advancing and could lead to potential sheath insertion difficulty.The iab must be inserted over a guidewire and a kinked/blocked central lumen would prevent the device from fully advancing in the patient.The root cause of how the central lumen became 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 intra-aortic balloon (iab) catheter couldn't be advanced through the sheath.As a result, a new kit was used and successfully inserted.Patient outcome reported as fine.There was no report of patient complication, serious injury or death.
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Search Alerts/Recalls
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