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Model Number IPN000260 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2021 |
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 when the doctor pushed through the guide wire, it was difficult to advanced.It was noted that the doctor found the central cavity was broken.As a result, the catheter was replaced.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of iab tight over guidewire is confirmed.During the investigation, the iabc central lumen was noted, damaged and broken.Which caused difficulty advancing the guidewire through the iabc central lumen.Additionally, dried blood was noted, within the helium pathway.A cross-over leak was confirmed, between the helium pathway and iabc c entral lumen, due to the damaged.And broken iabc central lumen within flex-tip assembly, which caused blood to enter the helium pathway.No other leaks were detected.The root cause of the damaged central lumen is undetermined.A non-conformance has been initiated to further investigate the issue.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 when the doctor pushed through the guide wire.It was difficult to advanced.It was noted, that the doctor found the central cavity was broken.As a result, the catheter was replaced.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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