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Model Number 45007 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 areas of shaft damage located 1cm from the tip to 16cm from the tip.The infusion line showed some ballooning damage located 77.5cm to 79cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use.A.014 test thruway guidewire was inserted into the device with no hesitations or restrictions.The device primed as designed.The device was activated, and the blades did spin as designed.The device ran for a period of 1 minute in the blades down mode.The device was put into the blades up mode and ran for a period of 30 seconds and the blades stopped spinning.The motor was heard and continued to spin.The devices pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft.When the pinion gear slides off the shaft and does not contact the motor gear, rotation of the blades would stop.The gear was slid back onto the shaft and reengaged with the motor gear and the device was run again.The devices blades did not rotate as the gear was spinning on the shaft.
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Event Description
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Reportable based on device analysis completed on 10nov2021.A 2.4mm jetstream xc catheter was selected for use to treat peripheral artery disease (pad).Pedal access was used to reach the target lesion.As the device was advanced, while inside of the patient, there was difficulty/resistance with advancement.Kinking, buckling, and some malformations were noted on the shaft, and it could not be loaded back onto the guidewire after it was removed from the patient.The procedure was completed and there were no patient complications reported.However, device analysis revealed the blades stopped spinning.
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Manufacturer Narrative
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H6 - evaluation conclusion code: updated.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 areas of shaft damage located 1cm from the tip to 16cm from the tip.The infusion line showed some ballooning damage located 77.5cm to 79cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use.A.014 test thruway guidewire was inserted into the device with no hesitations or restrictions.The device primed as designed.The device was activated, and the blades did spin as designed.The device ran for a period of 1 minute in the blades down mode.The device was put into the blades up mode and ran for a period of 30 seconds and the blades stopped spinning.The motor was heard and continued to spin.The devices pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft.When the pinion gear slides off the shaft and does not contact the motor gear, rotation of the blades would stop.The gear was slid back onto the shaft and reengaged with the motor gear and the device was run again.The devices blades did not rotate as the gear was spinning on the shaft.
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Event Description
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Reportable based on device analysis completed on 10nov2021.A 2.4mm jetstream xc catheter was selected for use to treat peripheral artery disease (pad).Pedal access was used to reach the target lesion.As the device was advanced, while inside of the patient, there was difficulty/resistance with advancement.Kinking, buckling, and some malformations were noted on the shaft, and it could not be loaded back onto the guidewire after it was removed from the patient.The procedure was completed and there were no patient complications reported.However, device analysis revealed the blades stopped spinning.
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Search Alerts/Recalls
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