Catalog Number AI-07155-KS |
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 02/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).See mdr #3010532612-2018-00030 and tc (b)(4) for related complaint.
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Event Description
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It was reported that the introducer wire in the pacer kit was attempted to advance over the needle with no success.It seems that the wire was getting stuck at the hub of the needle.Another kit with a different lot was used successfully.There was no patient complications.There was no reported patient death or serious injury.
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Manufacturer Narrative
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(b)(4).See mdr #3010532612-2018-00030 and (b)(4) for related complaint.Teleflex received the device for investigation.The reported complaint of dilator blocked is not confirmed.No damage or abnormalities was noted on the returned dilator and sheath.The guidewire advanced freely through the dilator.Although, the root cause of the complaint is undetermined the returned samples passed visual and functional test specifications.No further action required.
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Event Description
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It was reported that the introducer wire in the pacer kit was attempted to advance over the needle with no success.It seems that the wire was getting stuck at the hub of the needle.Another kit with a different lot was used successfully.There was no patient complications.There was no reported patient death or serious injury.
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Search Alerts/Recalls
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