|
Model Number 45030 |
Device Problems
Difficult to Advance (2920); Mechanical Jam (2983)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/11/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were microscopically and visually inspected.Blood was present inside the device and the waste bag was cut-off, when received.Inspection of the device revealed that there were numerous kinks throughout the shaft, with the shaft twisted 34cm distal of the strain relief and 23cm - 25cm proximal from the tip.The shaft also had damage that was consistent to a guidewire being pushed into the shaft from the inside 25cm proximal of the tip.The hypotube was found to be separated at the same location 25cm proximal of the tip.The tip was also damaged.The id (inner diameter) of the hub and tip was measured and was within specification.A test guidewire was used for functional testing and the wire was able to be inserted into the tip and advanced; however, the wire met resistance when trying to pass through the catheter due to the damage to the shaft of the device.
|
|
Event Description
|
Reportable based on device analysis completed on 22sep2020.It was reported that guidewire restriction occurred.The target lesions were located in the tibial arteries.After inserting a 0.014 pt2 guidewire, an angiojet solent dista catheter was advanced for treatment.During the procedure, after flushing the catheter well, power pulse spray was done with actyleaze along the segment from popliteal and posterior tibial artery and left for 50 minutes.The procedure was continued, however, some resistance in the wire movement inside the catheter was encountered and suddenly it stuck in the catheter.The devices were removed together and then the catheter was removed from the wire outside the patient's body.An angiojet solent omni catheter was used on the same pt2 wire and the procedure was completed.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hypotube break.
|
|
Search Alerts/Recalls
|
|
|