Catalog Number GEZ6200US7B |
Device Problems
Leak/Splash (1354); Suction Problem (2170); Deformation Due to Compressive Stress (2889)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/06/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
An export stand alone catheter was used during a procedure to treat a non-calcified, non-tortuous lesion exhibiting 100% stenosis in the mid sfa/popliteal.There was no damage noted to the packaging.The device was removed from packaging per ifu with no issues.The device was prepped per ifu with no issues.There was no resistance encountered when advancing the device and excessive force was not used.It was reported that the device failed to aspirate.There were 5 successful aspirations prior to the issue.The patient is alive with no injury.
|
|
Manufacturer Narrative
|
Additional information: there was no noticeable resistance to wire movement.There was no wire management issue during use.The procedure was successfully completed.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Received for analysis was one 7f export aspiration catheter.One 30ml vaclok syringe and aspiration line were also returned.No damage noted to either the syringe or aspiration line.A torsional kink was noted on the catheter located approx 23.5cm and another kink was noted 57.5cm from the strain relief.In attempt to aspirate the device, a leak was noted coming from the torsionally kinked site located approx.23.5cm from the strain relief.Closer inspection revealed a hole, resulting in water leaking out of the catheter shaft.Exposed wire braid was evident.Aspiration could not be performed.The id of the guidewire lumen was verified using a 0.015¿ mandrel.No other deformation noted.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|