Model Number 24700 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/30/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device was broken.A 3.0x40x90 (4f) sterling balloon catheter was selected for use.During preparation outside the patient, the device appeared to be frayed or disintegrated at the end of the wire.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that the device was broken.A 3.0x40x90 (4f) sterling balloon catheter was selected for use.During preparation outside the patient, the device appeared to be frayed or disintegrated at the end of the wire.There were no patient complications reported.
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Search Alerts/Recalls
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