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Model Number 45031 |
Device Problems
Display or Visual Feedback Problem (1184); Leak/Splash (1354); Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2023 |
Event Type
malfunction
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Event Description
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Reportable based on the device analysis completed on 26 apr 2023.It was reported that an error message occurred.The target lesion was located in the left superficial femoral artery.An angiojet solent omni was used for thrombectomy procedure.However, during the procedure, the device indicated that the saline was filled, but the capsule had a lot of liquid inside and no signs of leakage under the pump.The device was turned on and primed again, but it stopped at twelve seconds and gave another alert.This time, there was liquid leaking under the pump and priming was not possible.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis confirmed a hypotube break.
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Manufacturer Narrative
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E1: facility name: (b)(6).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 26 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.No pressure reading 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.The complaint was confirmed for under pressure issues related to a broken hypotube.Kinks were also confirmed.
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Search Alerts/Recalls
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