Model Number 7015 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/26/2019 |
Event Type
malfunction
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Event Description
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It was reported that tip detachment occurred.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, during introduction, it was noted the distal tip of the device was fractured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation at 59.4cm distal of the strain relief.The balloon was tightly folded.Microscopic inspection revealed tip damage.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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Event Description
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It was reported that tip detachment occurred.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, during introduction, it was noted the distal tip of the device was fractured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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