Model Number 45007 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: the event date was not provided and estimated to (b)(6) 2021.Device eval by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed multiple kinks located 1cm from the tip.There was blood in the aspiration line.The functionality of the device was checked by setting up the product per the ifu.The device primed as designed.The device was activated, and the blades did not spin as designed.The devices motor was heard; however, no tip rotation was noticed.The devices pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft.When the gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop.
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Event Description
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Reportable based on device analysis completed (b)(6) 2021.It was reported that the device stopped working.A 2.4mm jetstream catheter was selected for use in an atherectomy procedure.During use, the device stopped working and lost power and could not be reactivated.A new jetstream was used to complete the procedure.There were no patient complications.However, device analysis revealed the motor was functional but the blades would not rotate.
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Manufacturer Narrative
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B3 - date of event: the event date was not provided and estimated to (b)(6) 2021.H6 - evaluation conclusion code: updated to quality control deficiency.Device eval by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed multiple kinks located 1cm from the tip.There was blood in the aspiration line.The functionality of the device was checked by setting up the product per the ifu.The device primed as designed.The device was activated, and the blades did not spin as designed.The devices motor was heard; however, no tip rotation was noticed.The devices pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft.When the gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop.
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Event Description
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Reportable based on device analysis completed (b)(6) 2021.It was reported that the device stopped working.A 2.4mm jetstream catheter was selected for use in an atherectomy procedure.During use, the device stopped working and lost power and could not be reactivated.A new jetstream was used to complete the procedure.There were no patient complications.However, device analysis revealed the motor was functional but the blades would not rotate.
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Search Alerts/Recalls
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