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Model Number IPN000260 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2021 |
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 after the balloon implantation, it was found that the sheath tube of the dilator with a sheath was damaged.As a result, a new catheter was used.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 of sheath damaged is confirmed.During the visual investigation, a puncture/cut was found on the teflon sheath extrusion and can result in a leak.The damage was found near the teflon sheath hub and was consistent with contact from a sharp object.No other damaged was noted to the sheath.The returned intra-aortic balloon catheter (iabc) passed visual and functional test specifications.The root cause of the complaint is undetermined.The most probable potential cause is customer handling.The complaint is isolated, there are no other complaints with this finding.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 after the balloon implantation, it was found that the sheath tube of the dilator with a sheath was damaged.As a result, a new catheter was used.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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