Catalog Number 1003327 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/02/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
|
|
Event Description
|
It was reported during inflation of an unspecified balloon the indeflator contrast leakage was noted between the indeflator needle and the extension.The manometer did not measure pressure.Therefore, a new indeflator was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
|
Event Description
|
Subsequently, after the initial was filed it was noted that the leak was visible at the connection between the indeflator and balloon.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was returned for analysis.The device history record and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.The reported leak and the reported loose or intermittent connection were unable to be confirmed.As the reported loose/intermittent connection and the reported leak was unable to be confirmed during return analysis, it is possible that the connection port was not fully connected/tightened and/or the device being connected was compromised thus resulting in the reported difficulties; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak difficulties.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.
|
|
Search Alerts/Recalls
|