Catalog Number AI-07155-IK |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/17/2018 |
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 introducer was not securing to the sheath.Therefore the physician had to remove the pacemaker wire and start from the beginning and exchange of the sheath with a new kit, which ultimately worked.There was no report of patient death, serious injury or complications.
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Event Description
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It was reported that the introducer was not securing to the sheath.Therefore the physician had to remove the pacemaker wire and start from the beginning and exchange of the sheath with a new kit, which ultimately worked.There was no report of patient death, serious injury or complications.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of dilator/sheath would not lock during use is not confirmed.The returned sample passed dimensional specifications and the dilator was able to advance through the sheath and lock with the sheath hub.Although, the root cause of the complaint is undetermined the returned device passed functional test specifications.No further action required at this time.
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Search Alerts/Recalls
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