Model Number 7010 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/24/2020 |
Event Type
malfunction
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Event Description
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It was reported that a shaft break occurred.When a 3.0mm x 12mm quantum maverick balloon catheter was unpacked, it was noted that the device was fractured into two pieces.The device never entered into the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
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Event Description
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It was reported that a shaft break occurred.When a 3.0mm x 12mm quantum maverick balloon catheter was unpacked, it was noted that the device was fractured into two pieces.The device never entered into the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 83.1cm distal of the strain relief.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
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Search Alerts/Recalls
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