Model Number 45007 |
Device Problems
Entrapment of Device (1212); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: event date was not reported and was approximated to (b)(6) 2020.
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Event Description
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It was reported that the device became stuck on the wire, requiring additional intervention to remove.A 2.4mm jetstream xc was selected for use in an atherectomy procedure in the superficial femoral artery.After performing atherectomy, an attempt was made to remove the device over the non-boston scientific guidewire, but the devices became stuck together.The jetstream was unable to be removed.Therefore, the device was cut with scissors and removed.The guidewire was noted to have been accidentally kinked.No patient complications were reported.
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Event Description
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It was reported that the device became stuck on the wire, requiring additional intervention to remove.A 2.4mm jetstream xc was selected for use in an atherectomy procedure in the superficial femoral artery.After performing atherectomy, an attempt was made to remove the device over the non-boston scientific guidewire, but the devices became stuck together.The jetstream was unable to be removed.Therefore, the device was cut with scissors and removed.The guidewire was noted to have been accidentally kinked.No patient complications were reported.It was further reported that the guidewire entrapment occurred when the jetstream during removal from the sheath.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis without the guidewire.The catheter shaft showed extreme damage, including a separated shaft.There was buckling and kinks throughout the shaft.The functionality of the device could not be completed due to the damage on the device.Inspection of the remainder of the device revealed no other damage or irregularities.The device was confirmed for guidewire sticking due to the extreme damage on the shaft.
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Event Description
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It was reported that the device became stuck on the wire, requiring additional intervention to remove.A 2.4mm jetstream xc was selected for use in an atherectomy procedure in the superficial femoral artery.After performing atherectomy, an attempt was made to remove the device over the non-boston scientific guidewire, but the devices became stuck together.The jetstream was unable to be removed.Therefore, the device was cut with scissors and removed.The guidewire was noted to have been accidentally kinked.No patient complications were reported.It was further reported that the guidewire entrapment occurred when the jetstream during removal from the sheath.
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Search Alerts/Recalls
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