Catalog Number 1003331 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
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.
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Event Description
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It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.
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Event Description
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It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the copilot could not maintain screwing of the valve and always returned back counterclockwise.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified another copilot bleedback control valve was returned.The account confirmed another copilot was attempted to be used but the same issue of leakage occurred.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported loose/intermittent connection and the reported leak were unable to be confirmed.Device history record (dhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As the reported difficulties were unable to be confirmed during returned device analysis, it is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect and/or the port of the device being connected was compromised resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Additionally, 19 sterile unused devices were returned (part number: 1003331, lot 60473838).13 randomly selected units were visually inspected with no anomalies noted.All 13 units were functionally tested.All connections formed a secured connection without any anomalies.The indeflator was pressurized to 400psi with no leak noted, maintained pressure.A proxy catheter was connected to the copilot with no anomalies noted.
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Search Alerts/Recalls
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