BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
|
Back to Search Results |
|
Model Number 45007 |
Device Problems
Mechanical Problem (1384); Suction Problem (2170)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/16/2018 |
Event Type
malfunction
|
Event Description
|
It was reported that the blades would not go down and the device was not aspirating successfully.A 2.1mm jetstream xc catheter was selected for use for an atherectomy procedure.During procedure, while the physician attempted to go into rex mode, it was noted that the blades could not be retracted into blades down mode.Also, the device was not aspirating successfully.The blades were rotating on and off.The system was then shut down and the catheter was removed.The procedure was completed with another device.There were no patient complications reported.
|
|
Event Description
|
It was reported that the blades would not go down and the device was not aspirating successfully.A 2.1mm jetstream xc catheter was selected for use for an atherectomy procedure.During procedure, while the physician attempted to go into rex mode, it was noted that the blades could not be retracted into blades down mode.Also, the device was not aspirating successfully.The blades were rotating on and off.The system was then shut down and the catheter was removed.The procedure was completed with another device.There were no patient complications reported.Device evaluated by mfr: visual inspection showed 2 kinks on the device.The first kink was located 48cm from the tip and the 2nd kink which was much more severe and was located at 62cm from the tip.Functional testing revealed the device primed and did not function as design.The blades did not rotate.The shaft was dissected at the most severe kink and it was noticed that the drive coil was kinked a damaged.The coils started to unravel.With this damage the rotation of the blades would not be possible.This damage may be caused by pushing, pulling and torqueing of the device during the procedure.Since the device would not function the shaft was further dissected to inspect for any clot burden that may cause an aspiration issue.No occlusion was found during this analysis.
|
|
Search Alerts/Recalls
|
|
|