Catalog Number C12059 |
Device Problems
Break (1069); Deformation Due to Compressive Stress (2889); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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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.B3: date of event estimated as (b)(6) 2023.
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Event Description
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It was reported that the pressurewire x wire device was inserted into an unspecified catheter prior to use.However, the device became broken and no signal was displayed.The procedure continued with a new pressurewire x wire device.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequent to the initially filed report, it was reported that the pressurewire x wire device was inserted into an unspecified catheter which was inside the patient, however, the device became kinked and signal was lost between the device and the system.The device was removed and the procedure continued with a new pressurewire x wire device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Visual and functional analysis was performed on the returned device.The reported communication or transmission problem was not confirmed.During functional testing, the pressurewire was able to be connected and calibrated with a quantien system.The reported bends/kinks were 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 revealed no other similar complaints reported from this lot.The investigation was unable to determine a cause for the reported communication or transmission problem.It may be possible that an insufficient electrical contact occurred between guidewire and pwx transmitter; however, this could not be confirmed.The bends/kinks may be the result of inadvertent mishandling or interaction with the guiding catheter during advancement.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: health effect - impact code 2645 was removed, 2199 was added.H6: medical device problem code device code 1069 was removed, 2889 added.
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Search Alerts/Recalls
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