Model Number B1040-040 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during preparation of a 4x40mm armada 35 balloon catheter negative pressure was applied and a sucking sound could be heard; it was determined that the balloon had a perforation.The balloon catheter was not used and there was no patient involvement.The procedure was successfully completed with an unspecified balloon catheter.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Visual and functional analysis was performed on the returned device.The reported leak was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.The investigation has determined that the reported leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.
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Search Alerts/Recalls
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