Model Number 6531 |
Device Problem
Break (1069)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: used the first date of the month of the aware date as no event date was provided.
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Event Description
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It was reported that shaft break occurred.A 12mm x 2.25mm nc quantum apex balloon catheter was opened for use.However, it was noted that the device was fractured.
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Manufacturer Narrative
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B3 date of event: used the first date of the month of the aware date as no event date was provided.Returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 47.5cm and 50.1cm distal from the strain relief.There was blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported broken shaft.
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Event Description
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It was reported that shaft break occurred.A 12mm x 2.25mm nc quantum apex balloon catheter was opened for use.However, it was noted that the device was fractured.
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Search Alerts/Recalls
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