Catalog Number 1000184 |
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 06/19/2023 |
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 mildly calcified, mildly tortuous right coronary artery that is 90% stenosed.The indeflator was attempted to reach 30 atmospheres; however, the indeflator would only go up to 20 atmospheres during the procedure.It was noted that there was a loose connection between the indeflator and another device.Therefore, a new indeflator was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.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 did not indicate a lot specific quality issue.It is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however as the device was not returned for analysis this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and 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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