|
Model Number 7840 |
Device Problems
Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/19/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that foreign material was present in the device.An expo diagnostic catheter was selected for use.During the procedure, the catheter was advanced in patient.However, an attempt to load the wire, the wire was not successful due to a white plastic piece being lodged in the catheter.The procedure was completed using an alternate device.No patient complications were reported.
|
|
Event Description
|
It was reported that foreign material was present in the device.An expo diagnostic catheter was selected for use.During the procedure, the catheter was advanced in patient.However, an attempt to load the wire, the wire was not successful due to a white plastic piece being lodged in the catheter.The procedure was completed using an alternate device.No patient complications were reported.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection found inner liner delamination.A photo provided by the customer depicted the catheter with the tip cut and the inner liner separated next to the tip.
|
|
Search Alerts/Recalls
|
|
|