Catalog Number 1011534-15 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat the renal artery with moderate calcification, mild tortuosity and 80% stenosis.The 6.0x15 mm herculink elite stent delivery system (sds) could not be visualized angiographically so it was removed.Another unspecified sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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A visual inspection was performed on the returned device.The reported difficult or delayed positioning (poor visibility) was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported difficult or delayed positioning (poor visibility).There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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