Catalog Number AI-07155 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2017 |
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 event occurred in the emergency room.During insertion of the pacing catheter the balloon did not inflate.The catheter was removed.There was no reported patient death, injury or complications.There was a delay in therapy however no harm to patient.More information received: the ai-07155 was pre-tested using the syringe in the set.Upon insertion the balloon did not inflate (the balloon did not burst) another ai-07155 was inserted via the same insertion site without any problems.The patient outcome is ok.
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Manufacturer Narrative
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(b)(4).Teleflex received the reported device for analysis.The reported complaint of "balloon did not inflate" is not confirmed.The catheter balloon was successfully inflated.The device passed functional testing.The root cause of the complaint is undetermined.No further action required.
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Event Description
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It was reported that the event occurred in the emergency room.During insertion of the pacing catheter the balloon did not inflate.The catheter was removed.There was no reported patient death, injury or complications.There was a delay in therapy however no harm to patient.More information received: the ai-07155 was pre-tested using the syringe in the set.Upon insertion the balloon did not inflate (the balloon did not burst) another ai-07155 was inserted via the same insertion site without any problems.The patient outcome is ok.
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Search Alerts/Recalls
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