Catalog Number RSINT25012X |
Device Problems
Device Expiration Issue (1216); Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2016 |
Event Type
Malfunction
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Event Description
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It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a calcified and tortuous lesion in the mid lcx.
It was reported that the lesion was dilated several times but the device failed to cross the target lesion.
The device was used approximately 13 days post its use by date.
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Manufacturer Narrative
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The device was inspected prior to use with no issues noted.
The product is sold on consignment.
The account have a signed consignment agreement.
Patient is stable.
Procedure was completed with a resolute onyx drug-eluting stent.
Event date updated.
Event occurred prior to expiration date.
Product was used before expiry date.
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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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Search Alerts/Recalls
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