Model Number 3520 |
Device Problem
Entrapment of Device (1212)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/18/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that the rotapro became stuck on the rotawire.A 1.25mm rotapro and rotawire were selected for an atherectomy procedure.During the procedure, the rotawire became stuck inside the rotapro when performing dynaglide.Another 1.25mm rotapro and rotawire were used to complete the procedure.There were no patient complications reported and the procedure was fine.
|
|
Event Description
|
It was reported that the rotapro became stuck on the rotawire.A 1.25mm rotapro and rotawire were selected for an atherectomy procedure.During the procedure, the rotawire became stuck inside the rotapro when performing dynaglide.Another 1.25mm rotapro and rotawire were used to complete the procedure.There were no patient complications reported and the procedure was fine.It was further reported that the target lesion was located inside the left anterior descending artery.The rotawire became stuck inside the rotapro while advancing the rotapro system through the guide catheter.
|
|
Manufacturer Narrative
|
Device technical analysis: the wire was returned inside the related rotapro device.The rotawire was able to be removed from the rotapro device with little issue.There are numerous kinks along the wire.The floppy tip of the wire is stretched.The outer diameter of the wire was measured and found to be within specification.
|
|
Event Description
|
It was reported that the rotapro became stuck on the rotawire.A 1.25mm rotapro and rotawire were selected for an atherectomy procedure.During the procedure, the rotawire became stuck inside the rotapro when performing dynaglide.Another 1.25mm rotapro and rotawire were used to complete the procedure.There were no patient complications reported and the procedure was fine.It was further reported that the target lesion was located inside the left anterior descending artery.The rotawire became stuck inside the rotapro while advancing the rotapro system through the guide catheter.
|
|
Search Alerts/Recalls
|