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Model Number M00550601 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.
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Event Description
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It was reported to boston scientific corporation that an alliance inflation syringe was used during a procedure performed on (b)(6), 2023.During the procedure, the balloon was inflated, but the gauge remained at 0.However, the patient started reacting to the increased size of the balloon.To avoid further complications, the balloon was immediately deflated.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results: the customer reported that the device was disposed and will not be returned.As such, physical analysis has not been conducted in our laboratory.However, a device history review was performed and determined that, based on the manufacturing date of the device, the gauge reading inaccurately was likely the result of the manufacturing process.With all the available information, although the device has not been returned, boston scientific determined that the gauge reading inaccurately was likely the result of the manufacturing process.The gauge being unable to read pressure was the result of an intermittently malfunctioning camera system that may not have detected and rejected the faulty device.A review of the manufacturing process identified that a test station had cameras out of focus, which resulted in the inability to detect gauges that did not meet acceptance criteria.Bsc initiated a corrective and preventive action (capa) investigation to determine the root cause of this issue.A review of camera data from 01 june 2022 to 28 july 2023 identified events where the vision system was intermittently malfunctioning, and alliance ii syringes with faulty gauges may not have been detected.The investigation determined that approximately (b)(4) of alliance ii syringes manufactured during this timeframe may have had faulty gauges that were not detected as intended.An inspection was implemented at the test station on 02 august 2023 to confirm vision system functionality.As a result of the capa investigation, bsc implemented a software update on the alliance ii syringe gauge inspection cameras to ensure that all products would be rejected at the test station if the cameras were out of focus.This solution was implemented on 06 december 2023, and there have been no gauge reading inaccurate complaints reported for devices manufactured since the solution was implemented.An investigation to address this problem has been completed.
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Event Description
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It was reported to boston scientific corporation that an alliance inflation syringe was used during a procedure performed on (b)(6) 2023.During the procedure, the balloon was inflated, but the gauge remained at 0.However, the patient started reacting to the increased size of the balloon.To avoid further complications, the balloon was immediately deflated.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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