Model Number U4150222 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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For the one reported event, the one device was returned to bd and evaluated.The company is still investigating the issue at this time.
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Event Description
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This report summarizes one malfunction event.A review of the event indicated that model u4150222 pta balloon dilatation catheter allegedly detached.These report was received from one source.Of the one event, did not involved patient with no reported patient contact.The patients' age ranged from (b)(6) years, weight was (b)(6) kgs.Of the reported patients, one was female.
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Event Description
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This report summarizes one malfunction event.A review of the event indicated that model u4150222 pta balloon dilatation catheter allegedly detached.These report was received from one source.Of the one event, did not involved patient with no reported patient contact.The patients' age ranged from 64 years, weight was 63 kgs.Of the reported patients, one was female.
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Manufacturer Narrative
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For the one reported event, lot number was provided and lot history review was performed.The device was returned.A visual inspection found the device was received in two separate segments.A completed detachment of the balloon from the catheter was noted, and a complete circumferential break of the guidewire lumen was noted.Therefore, the investigation is confirmed the reported detachment.The definitive root cause for the identified detachment could not be determined based on the available information.It is unknown if procedural issues contributed to the reported event.
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Search Alerts/Recalls
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