Catalog Number C12059 |
Device Problems
Material Separation (1562); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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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 during the procedure, the pressurewire x wireless device was to be used in the mildly calcified, mildly tortuous, left anterior descending (lad) artery.The device was calibrated and equalized without issue.The device was being advanced with resistance, when the tip of the device separated inside of the anatomy.A snare device was used to remove the separated tip, and an unspecified device was used successfully for the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.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 indication of a lot specific product quality issue.Based on the reported information, the investigation determined that the reported failure to advance resulting in material separation and unexpected medical intervention was likely due to circumstances of the procedure.It is likely that during the failed attempt to advance, the tip of the pressurewire was subjected to tensile or torsional loads beyond its design limits causing the guide wire to separate.Anatomical conditions likely contributed to the failure to advance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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