|
Model Number 45031 |
Device Problems
Display or Visual Feedback Problem (1184); Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/06/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluated by mfr.: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location at 1 cm from the tip, the hypotube was broken and completely separated.The device could not be functionally tested due to the extreme damage on the device.A pressure reading of 4.289 kpsi was reported before the console would stop the priming process and issue an under-pressure alarm.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
|
|
Event Description
|
Reportable based on device analysis completed on 14-aug-2023.It was reported that the device failed to prime, and an error occurred.The target location was located in the lower limb vein.An angiojet solent omni was used for thrombectomy procedure.During the procedure, under power pulse mode, the system alerted an error and priming stopped.After multiple attempts, the catheter could not be used, and error still exists.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a broken hypotube.
|
|
Search Alerts/Recalls
|
|
|