Model Number 7312 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.A 3.75mm x 12mm nc emerge balloon catheter was selected for use.However, it was noted that the shaft was broke 20cm from the hub.The procedure was completed with a non-bsc device.There were no patient complications reported and the patient was stable.
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Event Description
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It was reported that shaft break occurred.A 3.75mm x 12mm nc emerge balloon catheter was selected for use.However, it was noted that the shaft was broke 20cm from the hub.The procedure was completed with a non-bsc device.There were no patient complications reported and the patient was stable.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 62.2cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Search Alerts/Recalls
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