Catalog Number 1804350-38 |
Device Problems
Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H6- device code 2017 clarifier: incorrect prep.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Event Description
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It was reported that the procedure was to treat a lesion in the heavily calcified and mildly tortuous right coronary artery (rca).The 3.5x38mm xience skypoint stent delivery system (sds) was advanced to the lesion and once at the lesion site, the device was aspirated.After aspiration blood was observed in the unspecified inflation device [leak].As a result, the sds was removed without issue and the procedure was completed with a non-abbott device.There were no adverse patient effects reported, and no clinically significant delay reported.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported leak 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 similar incidents from this lot.It was reported that the xience skypoint stent delivery system (sds) was advanced to the lesion and once at the lesion site, the device was aspirated.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use lists delivery system preparation steps to be performed prior to delivery procedure steps.If performed in this order a leak would have been identified prior to being used in a patient.It is unknown if the ifu deviation(s) directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported leak.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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