Model Number RONYX35018UX |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2019 |
Event Type
Malfunction
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Manufacturer Narrative
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The device returned with a detachment on the hypotube 48.
5cm distal to the strain relief.
The hypotube material was oval and jagged on both sides of the detachment site.
A kink was evident on the hypotube 4.
5cm proximal to the detachment site.
No other damage evident to the remainder of the device.
If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a lesion in the right coronary artery (rca).
The device was inspected with no issues noted.
Negative prep was performed without issue.
The device was not kinked and re-straightened during use.
It was reported that the stent shaft fractured while advancing the device through the guide catheter.
It was able to be removed by removing the catheter.
The patient was reported to be alive with no injury.
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Search Alerts/Recalls
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