Catalog Number C12059 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/03/2023 |
Event Type
malfunction
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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.The investigation determined that the reported failure to advance and difficulty removing was related to circumstances of the procedure.It is likely that during the attempt to cross the lesion, while pushing against resistance, the pressurewire was damage/kinked resulting in resistance/difficulty during removal.It is likely that anatomical conditions contributed to the difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional pressurewire x device referenced in b5 is filed under separate medwatch report number.
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Event Description
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It reported that during the procedure, the two pressurewire x, wireless devices were calibrated and equalized normally.The devices were intended to be used in the lesion in the left circumflex coronary artery (lcx) with moderate calcification and tortuosity.There was resistance felt during advancement and the first device failed to cross the lesion.Therefore, the device was removed from the patient with resistance felt.A second pressurewire x device was intended to be used to continue the procedure; however, the second device failed to cross the lesion.Therefore, the device was removed from the patient with resistance noted.The procedure was completed with another pressurewire x device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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