Model Number 10595 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was cancelled.The target lesion area was located in the distal end of the left anterior descending artery.A stingray lp catheter re-entry device was selected for use in a percutaneous coronary intervention.During the procedure, balloon inflation was achieved on the second inflation attempt.However, a poorly shown image was noted.The device was simply pulled out.The procedure was cancelled.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.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.The device was soaked in a water bath for two days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a crack in the manifold that prevented the device from inflating.The device was x-rayed, and the marker bands were detected.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 procedure was cancelled.The target lesion area was located in the distal end of the left anterior descending artery.A stingray lp catheter re-entry device was selected for use in a percutaneous coronary intervention.During the procedure, balloon inflation was achieved on the second inflation attempt.However, a poorly shown image was noted.The device was simply pulled out.The procedure was cancelled.There were no patient complications reported.
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Search Alerts/Recalls
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