Catalog Number AI-07155-IK |
Device Problem
Fluid/Blood Leak (1250)
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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 a 5f pacing wire/6f introducer kit was used on a patient.Some difficulties were experienced: the introducer was not securing to the sheath.The hemostatic valve appeared to be defective as once they tried to secure the pacing wire, they continued to have bleed back through the valve.Ultimately, the physician had to remove the pacemaker wire and start from the beginning and exchange sheaths with a new kit, which ultimately worked.There was no report of patient injury or consequence.
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Event Description
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It was reported that a 5f pacing wire/6f introducer kit was used on a patient.Some difficulties were experienced: the introducer was not securing to the sheath.The hemostatic valve appeared to be defective as once they tried to secure the pacing wire, they continued to have bleed back through the valve.Ultimately, the physician had to remove the pacemaker wire and start from the beginning and exchange sheaths with a new kit, which ultimately worked.There was no report of patient injury or consequence.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of sheath leaked is not confirmed.No leaks were noted from the returned sheath.Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications.No further action required at this time.
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Search Alerts/Recalls
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