Model Number IPN000263 |
Device Problem
Failure to Advance (2524)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that the intra-aortic balloon (iab) cannot pass through the introducer sheath.As a result, the iab was replaced, and inserted using the same insertion site.There was no report of patient complications, serious injury, or death.
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Manufacturer Narrative
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(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of that the "balloon cannot pass through the i introducer sheath" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon (iab) cannot pass through the introducer sheath.As a result, the iab was replaced and inserted using the same insertion site.There was no report of patient complications, 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 the "balloon cannot pass through the introducer sheath" is not confirmed.The returned intra-aortic balloon catheter (iabc) had previously been fully advanced through the correct supplied sheath and the sheath moved freely on the catheter during the investigation.No issues were found with the sheath and the iabc.The returned iabc bladder membrane passed dimensional and functional inspection.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 risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon (iab) cannot pass through the introducer sheath.As a result, the iab was replaced and inserted using the same insertion site.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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